Events

Device Recall Maximo II CRT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc. Cardiac Rhythm Managment 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
    50137
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0667-2009
  • 사례 시작날짜
    2008-07-25
  • 사례 출판 날짜
    2009-01-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74806
  • 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
    implantable pacemaker defibrillator - Product Code NIK
  • 원인
    Maximo ii vr icd, dr icd and crt-d inadvertently include the capture management algorithm (atrial/right ventricular/left ventricular capture management). the capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm.
  • 조치
    A Medtronic Inc. letter dated July 30, 2008 was sent to Physicians. The letter described the product and problem. The letter advised to contact Technical Services for specific questions regarding the care of patients or how to program the Maximo II devices. The letter instructed to collect and hold all non-implanted Maximo II devices and that a Medtronic Representative will contact the doctor to make arrangements to update the programmer 2090.

Device

Device Recall Maximo II CRT
  • 모델명 / 제조번호(시리얼번호)
    Lot Serial No PZP600096S PZP600610S PZP600608S PZP600546S PZP600149S PZP600569S PZP600587S PZP600589S PZP600612S PZP600450S PZP600557S PZP600193S PZP600558S PZP600559S PZP600531S PZP600533S PZP600534S PZP600535S PZP600536S PZP600199S PZP600215S PZP600473S PZP600474S PZP600475S PZP600476S PZP600477S PZP600478S PZP600479S PZP600480S PZP600607S PZP600513S PZP600514S PZP600515S PZP600516S PZP600530S PZP600092S PZP600093S PZP600562S PZP600571S PZP600609S PZP600596S PZP600166S PZP600467S PZP600529S PZP600638S PZP600134S PZP600135S PZP600172S PZP600133S PZP600509S PZP600128S PZP600196S PZP600103S PZP600111S PZP600140S PZP600142S PZP600169S PZP600527S PZP600611S PZP600636S PZP600656S PZP600614S PZP600090S PZP600141S PZP600195S PZP600137S PZP600089S PZP600112S PZP600178S PZP600127S PZP600173S PZP600211S PZP600213S PZP600511S PZP600524S PZP600577S PZP600542S PZP600091S PZP600154S PZP600174S PZP600466S PZP600177S PZP600454S PZP600455S PZP600456S PZP600457S PZP600458S PZP600459S PZP600462S PZP600463S PZP600464S PZP600465S PZP600543S PZP600552S PZP600434S PZP600510S PZP600438S PZP600439S PZP600584S PZP600221S PZP600521S PZP600180S PZP600544S PZP600604S PZP600605S PZP600606S PZP600436S PZP600517S PZP600588S PZP600113S PZP600114S PZP600115S PZP600116S PZP600117S PZP600118S PZP600119S PZP600120S PZP600121S PZP600122S PZP600097S PZP600098S PZP600099S PZP600100S PZP600101S PZP600163S PZP600164S PZP600165S PZP600448S PZP600197S PZP600200S PZP600202S PZP600203S PZP600204S PZP600205S PZP600206S PZP600207S PZP600208S PZP600209S PZP600210S PZP600136S PZP600550S PZP600637S PZP600568S PZP600109S PZP600586S PZP600159S PZP600198S PZP600160S PZP600176S PZP600161S PZP600581S PZP600582S PZP600132S PZP600108S PZP600168S PZP600170S PZP600214S PZP600512S PZP600526S PZP600545S PZP600191S PZP600192S PZP600566S PZP600567S PZP600110S PZP600528S PZP600634S PZP600155S PZP600126S PZP600129S PZP600130S PZP600131S PZP600148S PZP600123S PZP600124S PZP600171S PZP600508S PZP600158S PZP600105S PZP600153S PZP600095S PZP600094S PZP600167S PZP600212S PZP600547S PZP600538S PZP600216S PZP600217S PZP600435S PZP600162S PZP600641S PZP600146S PZP600532S PZP600592S PZP600593S PZP600594S PZP600595S PZP600143S PZP600144S PZP600555S PZP600556S PZP600618S PZP600620S PZP600506S PZP600507S PZP600657S PZP600560S PZP600561S PZP600646S PZP600649S PZP600654S PZP600107S PZP600104S PZP600147S PZP600615S PZP600617S PZP600537S PZP600598S PZP600102S PZP600194S PZP600583S PZP600157S PZP600175S PZP600087S PZP600088S PZP600444S PZP600575S PZP600576S PZP600151S PZP600106S PZP600525S PZP600471S PZP600472S PZP600599S PZP600231S PZP600232S PZP600520S PZP600226S PZP600453S PZP600541S PZP600229S PZP600230S PZP600522S PZP600523S PZP600432S PZP600433S PZP600623S PZP600624S PZP600223S PZP600585S PZP600228S PZP600653S PZP600225S PZP600179S PZP600182S PZP600183S PZP600184S PZP600185S PZP600186S PZP600188S PZP600190S PZP600218S PZP600219S PZP600222S PZP600452S PZP600629S PZP600632S PZP600437S PZP600539S PZP600224S PZP600573S PZP600574S PZP600564S PZP600565S PZP600578S PZP600579S PZP600481S PZP600482S PZP600483S PZP600484S PZP600442S PZP600621S PZP600622S PZP600580S PZP600551S PZP600644S PZP600645S PZP600468S PZP600469S PZP600470S PZP600540S PZP600655S PZP600572S PZP600625S PZP600553S PZP600554S PZP600440S PZP600626S PZP600628S PZP600630S PZP600631S PZP600150S PZP600152S PZP600548S PZP600549S PZP600570S PZP600633S PZP600518S PZP600597S PZP600145S PZP600563S PZP600139S and PZP600643S.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.
  • 제품 설명
    Maximo II CRT D284TRK, for ventricular pacing and defibrillation.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Managment, 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