Events

Device Recall Medtronic Model 53401 Single Chamber External Pulse Generator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    80267
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2317-2018
  • 사례 시작날짜
    2018-06-06
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165007
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Pulse-generator, pacemaker, external - Product Code DTE
  • 원인
    A subset of medtronic model 53401 single chamber external pulse generators (epgs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected power on reset (por).
  • 조치
    Medtronic began notifying customers, via letter, on about 06/06/2018. Customers were instructed to verify if they possessed affected 53401 EPGs, if they did have affected EPGs to determine if the firmware was updated, to notify all appropriate personnel, to notify customers if the affected devices have been transferred, and to complete and return the Customer Confirmation Certificate. Instructions for determining if the EPG firmware has been updated include: 1) powering the unit on and viewing firmware version; 2) if the firmware version is 01.03.00 or greater, the EPG firmware has been updated with the correction; and 3) if firmware version is 01.02.00, the EPG firmware has not been updated. Medtronic requests that customers arrange to have their EPGs returned for the firmware update.

Device

Device Recall Medtronic Model 53401 Single Chamber External Pulse Generator
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers MDB01005EP, MDB01006EP, MDB01007EP, MDB01008EP, MDB01009EP, MDB01010EP, MDB01011EP, MDB01012EP, MDB01013EP, MDB01014EP, MDB01015EP, MDB01016EP, MDB01017EP, MDB01018EP, MDB01019EP, MDB01036EP, MDB01037EP, MDB01038EP, MDB01039EP, MDB01040EP, MDB01041EP, MDB01042EP, MDB01043EP, MDB01044EP, MDB01045EP, MDB01046EP, MDB01047EP, MDB01048EP, MDB01049EP,  MDB01050EP, MDB01051EP, MDB01052EP, MDB01053EP, MDB01054EP, MDB01055EP, MDB01056EP, MDB01057EP, MDB01058EP, MDB01060EP, MDB01061EP, MDB01062EP, MDB01063EP, MDB01064EP, MDB01065EP, MDB01066EP, MDB01067EP, MDB01068EP, MDB01069EP, MDB01070EP, MDB01071EP, MDB01072EP, MDB01073EP, MDB01074EP, MDB01075EP, MDB01076EP, MDB01077EP, MDB01078EP, MDB01079EP, MDB01080EP, MDB01081EP, MDB01082EP, MDB01083EP, MDB01084EP, MDB01085EP, MDB01086EP, MDB01087EP, MDB01088EP, MDB01089EP, MDB01090EP, MDB01091EP, MDB01092EP, MDB01093EP, MDB01094EP, MDB01095EP, MDB01096EP, MDB01097EP, MDB01098EP, MDB01099EP, MDB01100EP, MDB01101EP, MDB01102EP, MDB01103EP, MDB01104EP, MDB01105EP, MDB01106EP, MDB01107EP, MDB01108EP, MDB01109EP, MDB01110EP, MDB01111EP, MDB01112EP, MDB01113EP, MDB01114EP, MDB01115EP, MDB01116EP, MDB01117EP, MDB01118EP, MDB01119EP, MDB01120EP, MDB01121EP, MDB01122EP, MDB01123EP, MDB01124EP, MDB01125EP, MDB01126EP, MDB01127EP, MDB01128EP, MDB01129EP, MDB01130EP, MDB01131EP, MDB01132EP, MDB01133EP, MDB01134EP, MDB01135EP, MDB01177EP, MDB01178EP, MDB01179EP, MDB01180EP, MDB01181EP, MDB01182EP, MDB01183EP, MDB01184EP, MDB01185EP, MDB01186EP, MDB01187EP, MDB01188EP, MDB01189EP, MDB01190EP, MDB01191EP, MDB01192EP, MDB01193EP, MDB01194EP, MDB01195EP, MDB01196EP, MDB01197EP, MDB01198EP, MDB01199EP, MDB01200EP, MDB01201EP, MDB01202EP, MDB01203EP, MDB01204EP, MDB01205EP, MDB01206EP, MDB01207EP, MDB01208EP, MDB01209EP, MDB01210EP, MDB01211EP, MDB01212EP, MDB01213EP, MDB01214EP, MDB01215EP, MDB01216EP, MDB01217EP, MDB01218EP, MDB01219EP, MDB01220EP, MDB01221EP, MDB01222EP, MDB01223EP, MDB01224EP, MDB01225EP, MDB01226EP, MDB01227EP, MDB01228EP, MDB01229EP, MDB01230EP, MDB01231EP, MDB01232EP, MDB01233EP, MDB01234EP, MDB01235EP, MDB01236EP, MDB01237EP, MDB01238EP, MDB01239EP, MDB01240EP, MDB01241EP, MDB01242EP, MDB01243EP, MDB01244EP, MDB01245EP, MDB01246EP, MDB01247EP, MDB01248EP, MDB01249EP, MDB01250EP, MDB01251EP, MDB01252EP, MDB01253EP, MDB01254EP, MDB01255EP, MDB01256EP, MDB01257EP, MDB01258EP, MDB01259EP, MDB01260EP, MDB01261EP, MDB01262EP, MDB01263EP, MDB01264EP, MDB01265EP, MDB01266EP, MDB01267EP, MDB01268EP, MDB01269EP, MDB01270EP, MDB01271EP, MDB01272EP, MDB01273EP, MDB01274EP, MDB01275EP, MDB01276EP, MDB01381EP, MDB01382EP, MDB01383EP, MDB01384EP, MDB01385EP, MDB01386EP, MDB01387EP, MDB01388EP, MDB01389EP, MDB01390EP, MDB01391EP, MDB01392EP, MDB01393EP, MDB01394EP, MDB01395EP, MDB01396EP, MDB02001EP, MDB02002EP, MDB02003EP, MDB02004EP, MDB02005EP, MDB02006EP, MDB02007EP, MDB02008EP, MDB02009EP, MDB02010EP, MDB02011EP, MDB02012EP, MDB02013EP, MDB02014EP, MDB02015EP, MDB02016EP, MDB02017EP, MDB02018EP, MDB02019EP, MDB02021EP, MDB02022EP, MDB02023EP, MDB02024EP, MDB02025EP, MDB02026EP, MDB02027EP, MDB02031EP, MDB02032EP, MDB02033EP, MDB02034EP, MDB02035EP, MDB02036EP, MDB02038EP, MDB02039EP, MDB02041EP, MDB02043EP, MDB02044EP, MDB02045EP, MDB02046EP, MDB02049EP, MDB02050EP, MDB02051EP, MDB02054EP, MDB02055EP, MDB02056EP, MDB02057EP, MDB02060EP, MDB02061EP, MDB02062EP, MDB02063EP, MDB02064EP, MDB02065EP, MDB02066EP, MDB02067EP, MDB02068EP, MDB02069EP, MDB02070EP, MDB02071EP, MDB02072EP, MDB02074EP, MDB02075EP, MDB02076EP, MDB02077EP, MDB02078EP, MDB02079EP, MDB02080EP, MDB02081EP, MDB02082EP, MDB02083EP, MDB02084EP, MDB02085EP, MDB02086EP, MDB02087EP, MDB02088EP, MDB02089EP, MDB02090EP, MDB02091EP, MDB02093EP, MDB02094EP, MDB02095EP, MDB02096EP, MDB02097EP, MDB02098EP, MDB02099EP, MDB02100EP, MDB02101EP, MDB02102EP, MDB02103EP, MDB02104EP, MDB02105EP, MDB02106EP, MDB02107EP, MDB02108EP, MDB02109EP, MDB02110EP, MDB02111EP, MDB02185EP, MDB02186EP, MDB02188EP, MDB02189EP, MDB02190EP, MDB02191EP, MDB02192EP, MDB02193EP, MDB02194EP, MDB02195EP, MDB02196EP, MDB02197EP, MDB02198EP, MDB02199EP, MDB02200EP, MDB02201EP, MDB02202EP, MDB02203EP, MDB02204EP, MDB02205EP, MDB02206EP, MDB02207EP, MDB02209EP, MDB02210EP, MDB02211EP, MDB02212EP, MDB02213EP, MDB02214EP, MDB02215EP, MDB02216EP, MDB02217EP, MDB02218EP, MDB02219EP, MDB02220EP, MDB02221EP, MDB02222EP, MDB02223EP, MDB02224EP, MDB02225EP, MDB02226EP, MDB02227EP, MDB02228EP, MDB02229EP, MDB02230EP, MDB02231EP, MDB02232EP, MDB02233EP, MDB02234EP, MDB02235EP, MDB02236EP, MDB02237EP, MDB02238EP, MDB02239EP, MDB02240EP, MDB02241EP, MDB02242EP, MDB02243EP, MDB02244EP, MDB02315EP, MDB02316EP, MDB02317EP, MDB02318EP, MDB02319EP, MDB02320EP, MDB02321EP, MDB02322EP, MDB02323EP, MDB02324EP, MDB02325EP, MDB02326EP, MDB02327EP, MDB02329EP, MDB02330EP, MDB02331EP, MDB02332EP, MDB02333EP, MDB02334EP, MDB02335EP, MDB02336EP, MDB02338EP, MDB02339EP, MDB02340EP, MDB02341EP, MDB02342EP, MDB02343EP, MDB02344EP, MDB02346EP, MDB02347EP, MDB02349EP, MDB02350EP, MDB02351EP, MDB02352EP, MDB02600EP, MDB02601EP, MDB02602EP, MDB02603EP, MDB02605EP, MDB02606EP, MDB02607EP, MDB02608EP, MDB02609EP, MDB02610EP, MDB02611EP, MDB02612EP, MDB02613EP, MDB02614EP, MDB02615EP, MDB02616EP, MDB02617EP, MDB02618EP, MDB02619EP, MDB02620EP, MDB02622EP, MDB02623EP, MDB02624EP, MDB02625EP, MDB02626EP, MDB02627EP, MDB02628EP, MDB02632EP, MDB02633EP, MDB02634EP, MDB02635EP, MDB02636EP, MDB02637EP, MDB02638EP, MDB02640EP, MDB02641EP, MDB02642EP, MDB02643EP, MDB02644EP, MDB02645EP, MDB02646EP, MDB02647EP, MDB02649EP, MDB02650EP, MDB02651EP, MDB02652EP, MDB02653EP, MDB02654EP, MDB02655EP, MDB02656EP, MDB02657EP, MDB02659EP, MDB02661EP, MDB02662EP, MDB02663EP, MDB02664EP, MDB02665EP, MDB02670EP, MDB02671EP, MDB02672EP, MDB02673EP, MDB02674EP, MDB02675EP, MDB02676EP, MDB02677EP, MDB02678EP, MDB02679EP, MDB02680EP, MDB02681EP, MDB02683EP, MDB02684EP, MDB02685EP, MDB02686EP, MDB02687EP, MDB02688EP, MDB02689EP, MDB02700EP, MDB02701EP, MDB02702EP, MDB02703EP, MDB02704EP, MDB02705EP, MDB02706EP, MDB02707EP, MDB02708EP, MDB02709EP, MDB02710EP, MDB02711EP, MDB02712EP, MDB02714EP, MDB02715EP, MDB02716EP, MDB02717EP, MDB02718EP, MDB02719EP, MDB02763EP, MDB02764EP, MDB02765EP, MDB02766EP, MDB02767EP, MDB02768EP, MDB02769EP, MDB02817EP, MDB02818EP, MDB02819EP, MDB02820EP, MDB02821EP, MDB02822EP, MDB02823EP, MDB02824EP, MDB02825EP, MDB02826EP, MDB02827EP, MDB02828EP, MDB02829EP, MDB02831EP, MDB02832EP, MDB02833EP, MDB02834EP, MDB02835EP, MDB02836EP, MDB02837EP, MDB02838EP, MDB02839EP, MDB02840EP, MDB02842EP, MDB02843EP, MDB02845EP, MDB02846EP, MDB02847EP, MDB02848EP, MDB02849EP, MDB02851EP, MDB02852EP, MDB02853EP, MDB02854EP, MDB02855EP, MDB02856EP, MDB02857EP, MDB02858EP, MDB02859EP, MDB02860EP, MDB02861EP, MDB02862EP, MDB02863EP, MDB02864EP, MDB02865EP, MDB02866EP, MDB02867EP, MDB02868EP, MDB02869EP, MDB02870EP, MDB02871EP, MDB02872EP, MDB02873EP, MDB02874EP, MDB02875EP, MDB02876EP, MDB02877EP, MDB02879EP, MDB02880EP, MDB02881EP, MDB02882EP, MDB02883EP, MDB02884EP, MDB02885EP, MDB02886EP, MDB02897EP, MDB02898EP, MDB02899EP, MDB02900EP, MDB02902EP, MDB02903EP, MDB02904EP, MDB02905EP, MDB02906EP, MDB02989EP, MDB02990EP, MDB02991EP, MDB02993EP, MDB02994EP, MDB02995EP, MDB02996EP, MDB02997EP, MDB02998EP, MDB02999EP, MDB03000EP, MDB03001EP, MDB03002EP, MDB03003EP, MDB03004EP, MDB03005EP, MDB03007EP, MDB03008EP, MDB03009EP, MDB03010EP, MDB03011EP, MDB03012EP, MDB03013EP, MDB03014EP, MDB03015EP, MDB03017EP, MDB03018EP, MDB03019EP, MDB03020EP, MDB03021EP, MDB03022EP, MDB03023EP, MDB03024EP, MDB03025EP, MDB03026EP, MDB03027EP, MDB03028EP, MDB03029EP, MDB03031EP, MDB03032EP, MDB03033EP, MDB03034EP, MDB03036EP, MDB03037EP, MDB03038EP, MDB03040EP, MDB03041EP, MDB03042EP, MDB03043EP, MDB03044EP, MDB03045EP, MDB03046EP, MDB03047EP, MDB03048EP, MDB03049EP, MDB03050EP, MDB03051EP, MDB03052EP, MDB03053EP, MDB03054EP, MDB03055EP, MDB03056EP, MDB03057EP, MDB03058EP, MDB03059EP, MDB03060EP, MDB03061EP, MDB03063EP, MDB03141EP, MDB03142EP, MDB03143EP, MDB03144EP, MDB03145EP, MDB03146EP, MDB03149EP, MDB03150EP, MDB03151EP, MDB03152EP, MDB03153EP, MDB03154EP, MDB03155EP,  MDB03156EP, MDB03157EP, MDB03158EP, MDB03159EP, MDB03161EP, MDB03163EP, MDB03164EP, MDB03165EP, MDB03167EP, MDB03168EP, MDB03169EP, MDB03171EP, MDB03172EP, MDB03173EP, MDB03174EP, MDB03175EP, MDB03176EP, MDB03177EP, MDB03178EP, MDB03179EP, MDB03180EP, MDB03181EP, MDB03182EP, MDB03183EP, MDB03184EP, MDB03185EP, MDB03186EP, MDB03187EP, MDB03188EP, MDB03189EP, MDB03190EP, MDB03191EP, MDB03192EP, MDB03193EP, MDB03194EP, MDB03195EP, MDB03196EP, MDB03197EP, MDB03198EP, MDB03199EP, MDB03200EP, MDB03201EP, MDB03202EP,MDB03203EP, MDB03204EP, MDB03206EP, MDB03207EP, MDB03208EP, MDB03209EP, MDB03210EP, MDB03211EP, MDB03214EP, MDB03215EP, MDB03216EP, MDB03217EP, MDB03219EP, MDB03220EP, MDB03221EP, MDB03222EP, MDB03223EP, MDB03224EP, MDB03225EP, MDB03226EP, MDB03227EP, MDB03228EP, MDB03230EP, MDB03231EP, MDB03232EP, MDB03233EP, MDB03235EP, MDB03236EP, MDB03237EP, MDB03238EP, MDB03418EP, MDB03419EP, MDB03420EP, MDB03422EP, MDB03424EP, MDB03425EP, MDB03426EP, MDB03428EP, MDB03429EP, MDB03430EP, MDB03431EP, MDB03432EP, MDB03433EP, MDB03434EP, MDB03435EP, MDB03437EP, MDB03438EP, MDB03439EP, MDB03441EP, MDB03442EP, MDB03443EP, MDB03444EP, MDB03445EP, MDB03446EP, MDB03447EP, MDB03448EP, MDB03449EP, MDB03450EP, MDB03453EP, MDB03454EP, MDB03507EP, MDB03508EP, MDB03509EP, MDB03510EP, MDB03511EP, MDB03512EP, MDB03513EP, MDB03514EP, MDB03515EP, MDB03516EP, MDB03517EP, MDB03518EP, MDB03520EP, MDB03521EP, MDB03522EP, MDB03523EP, MDB03524EP, MDB03525EP, MDB03527EP, MDB03528EP, MDB03529EP, MDB03530EP, MDB03531EP, MDB03532EP, MDB03533EP, MDB03534EP, MDB03535EP, MDB03536EP, MDB03537EP, MDB03538EP, MDB03539EP, MDB03540EP, MDB03541EP, MDB03542EP, MDB03543EP, MDB03544EP, MDB03545EP, MDB03546EP, MDB03548EP, MDB03549EP, MDB03550EP, MDB03551EP, MDB03552EP, MDB03553EP, MDB03554EP, MDB03555EP, MDB03556EP, MDB03558EP, MDB03559EP, MDB03560EP, MDB03561EP, MDB03562EP, MDB03563EP, MDB03564EP, MDB03565EP, MDB03566EP, MDB03567EP, MDB03568EP, MDB03569EP, MDB03570EP, MDB03571EP, MDB03572EP, MDB03573EP, MDB03574EP, MDB03575EP, MDB03576EP, MDB03577EP, MDB03578EP, MDB03579EP, MDB03580EP, MDB03581EP, MDB03582EP, MDB03583EP, MDB03585EP, MDB03586EP, MDB03587EP, MDB03588EP, MDB03589EP, MDB03590EP, MDB03592EP, MDB03594EP, MDB03595EP, MDB03596EP, MDB03597EP, MDB03598EP, MDB03599EP, MDB03600EP, MDB03601EP, MDB03602EP, MDB03603EP, MDB03604EP, MDB03605EP, MDB03606EP, MDB03677EP, MDB03678EP, MDB03679EP, MDB03680EP, MDB03682EP, MDB03683EP, MDB03684EP, MDB03685EP, MDB03686EP, MDB03687EP, MDB03688EP, MDB03689EP, MDB03690EP, MDB03691EP, MDB03765EP, MDB03767EP, MDB03768EP, MDB03769EP, MDB03770EP, MDB03771EP, MDB03772EP, MDB03773EP, MDB03774EP, MDB03775EP, MDB03777EP, MDB03778EP, MDB03779EP, MDB03780EP, MDB03781EP, MDB03782EP, MDB03784EP, MDB03785EP, MDB03786EP, MDB03787EP, MDB03788EP, MDB03789EP, MDB03790EP, MDB03791EP, MDB03792EP, MDB03793EP, MDB03794EP, MDB03796EP, MDB03797EP, MDB03798EP, MDB03799EP, MDB03801EP, MDB03802EP, MDB03803EP, MDB03804EP, MDB03805EP, MDB03806EP, MDB03807EP, MDB03808EP, MDB03809EP, MDB03811EP, MDB03812EP, MDB03814EP, MDB03816EP, MDB03818EP, MDB03820EP, MDB03821EP, MDB03822EP, MDB03832EP, MDB03833EP, MDB03834EP, MDB03835EP, MDB03836EP, MDB03837EP, MDB03839EP, MDB03840EP, MDB03841EP, MDB03842EP, MDB03843EP, MDB03844EP, MDB03845EP, MDB03846EP, MDB03847EP, MDB04041EP, MDB04042EP, MDB04043EP, MDB04044EP, MDB04045EP, MDB04046EP, MDB04047EP, MDB04048EP, MDB04049EP, MDB04050EP, MDB04051EP, MDB04052EP, MDB04053EP, MDB04054EP, MDB04055EP, MDB04057EP, MDB04059EP, MDB04061EP, MDB04062EP, MDB04063EP, MDB04064EP, MDB04065EP, MDB04066EP, MDB04067EP, MDB04068EP, MDB04069EP, MDB04070EP, MDB04071EP, MDB04073EP, MDB04074EP, MDB04075EP, MDB04076EP, MDB04077EP, MDB04078EP, MDB04079EP, MDB04080EP, MDB04081EP, MDB04082EP, MDB04083EP, MDB04084EP, MDB04085EP, MDB04087EP, MDB04088EP, MDB04090EP, MDB04093EP, MDB04095EP, MDB04096EP, MDB04097EP, MDB04098EP, MDB04099EP, MDB04100EP, MDB01020GP, MDB01021GP, MDB01022GP, MDB01023GP, MDB01024GP, MDB01137GP, MDB01138GP, MDB01139GP, MDB01140GP, MDB01141GP, MDB01142GP, MDB01143GP, MDB01144GP, MDB01145GP, MDB01146GP, MDB01147GP, MDB01148GP, MDB01149GP, MDB01150GP, MDB01151GP, MDB01152GP, MDB01153GP, MDB01154GP, MDB01155GP, MDB01156GP, MDB02549GP, MDB02550GP, MDB02551GP, MDB02553GP, MDB02555GP, MDB02556GP, MDB02558GP, MDB02559GP, MDB02560GP, MDB02561GP, MDB02562GP, MDB02563GP, MDB02565GP, MDB02566GP, MDB02567GP, MDB02568GP, MDB02569GP, MDB02570GP, MDB02571GP, MDB02572GP, MDB02573GP, MDB02574GP, MDB02947GP, MDB02949GP, MDB02950GP, MDB02951GP, MDB02952GP, MDB02955GP, MDB02956GP, MDB02957GP, MDB02960GP, MDB02961GP, MDB03295GP, MDB03296GP, MDB03297GP, MDB03298GP, MDB03299GP, MDB03300GP, MDB03301GP, MDB01030IP, MDB01031IP, MDB01032IP, MDB01033IP, MDB01034IP, MDB01157IP, MDB01158IP, MDB01159IP, MDB01160IP, MDB01161IP, MDB01162IP, MDB01163IP, MDB01164IP, MDB01165IP, MDB01166IP, MDB01167IP, MDB01168IP, MDB01169IP, MDB01170IP, MDB01171IP, MDB01172IP, MDB01173IP, MDB01174IP, MDB01175IP, MDB01176IP, MDB02575IP, MDB02576IP, MDB02577IP, MDB02578IP, MDB02580IP, MDB02581IP, MDB02582IP, MDB02583IP, MDB02584IP,MDB02585IP, MDB02586IP, MDB02587IP, MDB02588IP, MDB02589IP, MDB02590IP, MDB02591IP, MDB02592IP, MDB02593IP, MDB02594IP, MDB02595IP, MDB02596IP, MDB02597IP, MDB02598IP, MDB02962IP, MDB02963IP, MDB02964IP, MDB02965IP, MDB02966IP, MDB02967IP, MDB02968IP, MDB02969IP, MDB02970IP, MDB02971IP, MDB02972IP, MDB01827FP, MDB01828FP, MDB01829FP, MDB01830FP, MDB01831FP, MDB01852FP, MDB01853FP, MDB01854FP, MDB01855FP, MDB01856FP, MDB02250FP, MDB02251FP, MDB02252FP, MDB02253FP, MDB02254FP, MDB02255FP, MDB02256FP, MDB02257FP, MDB02363FP, MDB02364FP, MDB02365FP, MDB02366FP, MDB02367FP, MDB02368FP, MDB02369FP, MDB02782FP, MDB02784FP, MDB02785FP, MDB02786FP, MDB02787FP, MDB02788FP, MDB02789FP, MDB02790FP, MDB02791FP, MDB02974FP, MDB02975FP, MDB02976FP, MDB02977FP, MDB02978FP, MDB02979FP, MDB02980FP, MDB02981FP, MDB03359FP, MDB03361FP, MDB03362FP, MDB03364FP, MDB03365FP, MDB03366FP, MDB03367FP, MDB03368FP, MDB03370FP, MDB03371FP, MDB03372FP, MDB03373FP, MDB03375FP, MDB03383FP, MDB03384FP, MDB03385FP, MDB03386FP, MDB03388FP, MDB03389FP, MDB03390FP, MDB03391FP, MDB03392FP, MDB04003FP, MDB04004FP, MDB04006FP, MDB04007FP, MDB01822SP, MDB01823SP, MDB01824SP, MDB01825SP, MDB01826SP, MDB01864SP, MDB01865SP, MDB01866SP, MDB01867SP, MDB01868SP, MDB02160SP, MDB02161SP, MDB02162SP, MDB02163SP, MDB02164SP, MDB02245SP, MDB02246SP, MDB02247SP, MDB02248SP, MDB02249SP, MDB02353SP, MDB02354SP, MDB02355SP, MDB02356SP, MDB02357SP, MDB02358SP, MDB02359SP, MDB02360SP, MDB02361SP, MDB02362SP, MDB02770SP, MDB02771SP, MDB02772SP, MDB02773SP, MDB02774SP, MDB02775SP, MDB02776SP, MDB02777SP, MDB02778SP, MDB02779SP, MDB02780SP, MDB02781SP, MDB02982SP, MDB02983SP, MDB02984SP, MDB02985SP, MDB02986SP, MDB02987SP, MDB02988SP, MDB01277UP, MDB01279UP, MDB01282UP, MDB01284UP, MDB01287UP, MDB01289UP, MDB01302UP, MDB01419UP, MDB01438UP, MDB01448UP, MDB01482UP, MDB01486UP, MDB01488UP, MDB01857UP, MDB01858UP, MDB01859UP, MDB01860UP, MDB01861UP, MDB01862UP, MDB01863UP, MDB01931UP, MDB01932UP, MDB01933UP, MDB01934UP, MDB01936UP, MDB01940UP, MDB01949UP, MDB01950UP, MDB01956UP, MDB01961UP, MDB01962UP, MDB01963UP, MDB01964UP, MDB01965UP, MDB01966UP, MDB01967UP, MDB01968UP, MDB01969UP, MDB01970UP, MDB01972UP, MDB01974UP, MDB01975UP, MDB01976UP, MDB01978UP, MDB01979UP, MDB01980UP, MDB01981UP, MDB01982UP, MDB01984UP, MDB01985UP, MDB01988UP, MDB01989UP, MDB01990UP, MDB01991UP, MDB01992UP, MDB01993UP, MDB01994UP, MDB01995UP, MDB01996UP, MDB01997UP, MDB01998UP, MDB01999UP, MDB02143UP, MDB02165UP, MDB02166UP, MDB02167UP, MDB02168UP, MDB02169UP, MDB02170UP, MDB02171UP, MDB02172UP, MDB02173UP, MDB02174UP, MDB02175UP, MDB02176UP, MDB02177UP, MDB02178UP, MDB02179UP, MDB02180UP, MDB02181UP, MDB02182UP, MDB02183UP, MDB02184UP, MDB02259UP, MDB02260UP, MDB02261UP, MDB02262UP, MDB02264UP, MDB02267UP, MDB02268UP, MDB02269UP, MDB02271UP, MDB02273UP, MDB02274UP, MDB02275UP, MDB02276UP, MDB02277UP, MDB02278UP, MDB02280UP, MDB02281UP, MDB02282UP, MDB02284UP, MDB02285UP, MDB02286UP, MDB02289UP, MDB02292UP, MDB02293UP, MDB02295UP, MDB02296UP, MDB02298UP, MDB02301UP, MDB02303UP, MDB02304UP, MDB02305UP, MDB02307UP, MDB02308UP, MDB02309UP, MDB02310UP, MDB02311UP, MDB02312UP, MDB02720UP, MDB02721UP, MDB02722UP, MDB02723UP, MDB02725UP, MDB02726UP, MDB02727UP, MDB02728UP, MDB02729UP, MDB02730UP, MDB02731UP, MDB02734UP, MDB02735UP, MDB02736UP, MDB02737UP, MDB02738UP, MDB02739UP, MDB02740UP, MDB02741UP, MDB02742UP, MDB02744UP, MDB02745UP, MDB02746UP, MDB02747UP, MDB02748UP, MDB02749UP, MDB02750UP, MDB02751UP, MDB02752UP, MDB02753UP, MDB02754UP, MDB02755UP, MDB02756UP, MDB02757UP, MDB02758UP, MDB02759UP, MDB02760UP, MDB02761UP, MDB02762UP, MDB02924UP, MDB02925UP, MDB02926UP, MDB02927UP, MDB02928UP, MDB02929UP, MDB02930UP, MDB02931UP, MDB02932UP, MDB02934UP, MDB02935UP, MDB02936UP, MDB02937UP, MDB02938UP, MDB02939UP, MDB02940UP, MDB02942UP, MDB02943UP, MDB02944UP, MDB02945UP, MDB02946UP, MDB01278UP, MDB01280UP, MDB01281UP, MDB01283UP, MDB01285UP, MDB01286UP, MDB01288UP, MDB01290UP, MDB01291UP, MDB01292UP, MDB01293UP, MDB01294UP, MDB01295UP, MDB01296UP, MDB01297UP, MDB01298UP, MDB01299UP, MDB01300UP, MDB01301UP, MDB01303UP, MDB01304UP, MDB01305UP, MDB01306UP, MDB01485UP, MDB01489UP, MDB01935UP, MDB01937UP, MDB01938UP, MDB01939UP, MDB01941UP, MDB01942UP, MDB01943UP, MDB01944UP, MDB01945UP, MDB01946UP, MDB01947UP, MDB01951UP, MDB01952UP, MDB01954UP, MDB01955UP, MDB01957UP, MDB01959UP, MDB01971UP, MDB01977UP, MDB01986UP, MDB02112UP, MDB02113UP, MDB02114UP, MDB02115UP, MDB02116UP, MDB02117UP, MDB02118UP, MDB02119UP, MDB02121UP, MDB02122UP, MDB02123UP, MDB02124UP, MDB02125UP, MDB02126UP, MDB02127UP, MDB02128UP, MDB02129UP, MDB02130UP, MDB02131UP, MDB02132UP, MDB02133UP, MDB02134UP, MDB02135UP, MDB02136UP, MDB02137UP, MDB02138UP, MDB02139UP, MDB02140UP, MDB02141UP, MDB02142UP, MDB02145UP, MDB02146UP, MDB02147UP, MDB02148UP, MDB02149UP, MDB02150UP, MDB02151UP, MDB02152UP, MDB02153UP, MDB02154UP, MDB02155UP, MDB02157UP, MDB02158UP, MDB02159UP, MDB02258UP, MDB02792UP, MDB02793UP, MDB02794UP, MDB02795UP, MDB02797UP, MDB02798UP, MDB02799UP, MDB02800UP, MDB02801UP, MDB02802UP, MDB02803UP, MDB02804UP, MDB02805UP, MDB02806UP, MDB02807UP, MDB02809UP, MDB02811UP, MDB02812UP, MDB02813UP, MDB02814UP, MDB02815UP, MDB02816UP, MDB02887UP, MDB02888UP, MDB02889UP, MDB02890UP, MDB02891UP, MDB02892UP, MDB02893UP, MDB02894UP, MDB02895UP, MDB02896UP, MDB02907UP, MDB02908UP, MDB02909UP, MDB02910UP, MDB02911UP, MDB02912UP, MDB02913UP, MDB02914UP, MDB02915UP, MDB02916UP, MDB02917UP, MDB02918UP, MDB02919UP, MDB02920UP, MDB02922UP, MDB02923UP, MDB03627UP, MDB03628UP, MDB03629UP, MDB03630UP, MDB03631UP, MDB03632UP, MDB03633UP, MDB03634UP, MDB03635UP, MDB03636UP, MDB03637UP, MDB03638UP, MDB03639UP, MDB03640UP, MDB03641UP, MDB03642UP, MDB03643UP, MDB03644UP, MDB03645UP, MDB03646UP, MDB03647UP, MDB03648UP, MDB03649UP, MDB03650UP, MDB03651UP, MDB03652UP, MDB03653UP, MDB03654UP, MDB03655UP, MDB03656UP, MDB03657UP, MDB03659UP, MDB03660UP, MDB03661UP, MDB03662UP, MDB03663UP, MDB03664UP, MDB03666UP, MDB03667UP, MDB03668UP, MDB03669UP, MDB03670UP, MDB03671UP, MDB03672UP, MDB03673UP, MDB03674UP, MDB03675UP, MDB03676UP, MDB03692UP, MDB03693UP, MDB03694UP, MDB03695UP, MDB03696UP, MDB03698UP, MDB03699UP, MDB03700UP, MDB03701UP, MDB03702UP, MDB03703UP, MDB03704UP, MDB03705UP, MDB03706UP, MDB03707UP, MDB03708UP, MDB03709UP, MDB03710UP, MDB03711UP, MDB03712UP, MDB03713UP, MDB03714UP, MDB03716UP, MDB03717UP, MDB03718UP, MDB03719UP, MDB03720UP, MDB03722UP, MDB03724UP, MDB03725UP, MDB03726UP, MDB03727UP, MDB03728UP, MDB03729UP, MDB03730UP, MDB03731UP, MDB03732UP, MDB03733UP, MDB03734UP, MDB03735UP, MDB03737UP, MDB03738UP, MDB03739UP, MDB03740UP, MDB03743UP, MDB03744UP, MDB03745UP, MDB03746UP, MDB03747UP, MDB03748UP, MDB03749UP, MDB03750UP, MDB03751UP, MDB03848UP, MDB03849UP, MDB03850UP, MDB03851UP, MDB03852UP, MDB03853UP, MDB03854UP, MDB03855UP, MDB03856UP, MDB03857UP, MDB03858UP, MDB03859UP, MDB03861UP, MDB03862UP, MDB03863UP, MDB03864UP, MDB03865UP, MDB03866UP, MDB03867UP, MDB03868UP, MDB03869UP, MDB03870UP, MDB03871UP, MDB03872UP, MDB03873UP, MDB03874UP, MDB03875UP, MDB03876UP, MDB03878UP, MDB03879UP, MDB03881UP, MDB03882UP, MDB03883UP, MDB03884UP, MDB03885UP, MDB03886UP, MDB03888UP, MDB03889UP, MDB03890UP, MDB03891UP, MDB03892UP, MDB03893UP, MDB03894UP, MDB03895UP, MDB03897UP, MDB03898UP, MDB03899UP, MDB03902UP, MDB03903UP, MDB03904UP, MDB03905UP, MDB03906UP, MDB03907UP, MDB03908UP, MDB03909UP, MDB03910UP, MDB03911UP, MDB03912UP, MDB03914UP, MDB03916UP, MDB03917UP, MDB03918UP, MDB03919UP, MDB03920UP, MDB03921UP, MDB03922UP, MDB03923UP, MDB03924UP, MDB03925UP, MDB03927UP, MDB03928UP, MDB03930UP, MDB03931UP, MDB03932UP, MDB03933UP, MDB03935UP, MDB03936UP, MDB03937UP, MDB03938UP, MDB03939UP, MDB03940UP, MDB03941UP, MDB03942UP, MDB03945UP, MDB03946UP, MDB03947UP, MDB03948UP, MDB03949UP, MDB03950UP, MDB03951UP, MDB03952UP, MDB03953UP, MDB03954UP, MDB03955UP, MDB03956UP, MDB03957UP, MDB03958UP, MDB03959UP, MDB03960UP, MDB03961UP, MDB03962UP, MDB03964UP, MDB03965UP, MDB03966UP, MDB03967UP, MDB03969UP, MDB03970UP, MDB03971UP, MDB03972UP, MDB03973UP, MDB03974UP, MDB03976UP, MDB03977UP, MDB03978UP, MDB03979UP, MDB03980UP, MDB03982UP, MDB03983UP, MDB03984UP, MDB03985UP, MDB03987UP, MDB03988UP, MDB03989UP, MDB03990UP, MDB03991UP, MDB03992UP, MDB03993UP, MDB03994UP, MDB03995UP, MDB03996UP, MDB04009UP, MDB04010UP, MDB04011UP, MDB04012UP, MDB04013UP, MDB04014UP, MDB04015UP, MDB04017UP, MDB04018UP, MDB04019UP, MDB04020UP, MDB04021UP, MDB04022UP, MDB04023UP, MDB04024UP, MDB04025UP, MDB04026UP, MDB04027UP, MDB04028UP, MDB04029UP, MDB04030UP, MDB04031UP, MDB04032UP, MDB04033UP, MDB04034UP, MDB04035UP, MDB04037UP, MDB04038UP, MDB04039UP, MDB04040UP, MDB02629EP, MDB02630EP, MDB02631EP.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Domestic distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Armenia, Austria, Bangladesh, Belgium, China, Dominican Republic, Finland, France, Germany, India, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, Nepal, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Sierra Leone, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Turkey, United Arab Emirates, United Kingdom.
  • 제품 설명
    Single Chamber Temporary External Pacemaker, Model 53401
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
  • 제조사 주소
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA