Device Recall Model 105 Aspire HC and Generators 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cyberonics, Inc 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
    77698
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3019-2017
  • 사례 시작날짜
    2017-06-13
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
  • 원인
    Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
  • 조치
    Affected hospitals were notified beginning on 06/13/2017 and prescribing physicians were notified beginning on 06/28/2017. Instructions for affected hospitals included examine inventory, quarantine any affected devices, return the devices, complete and return the response form. Instructions for prescribing physicians included to monitory patients frequently and perform diagnostic testing at each visit, ensure patients are using the device regularly to verify stimulation is felt, ensure patients notify their physician if stimulation changes, and complete and return the response form.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial No. (Exp Date): 35283 (01/22/2017), 35339 (01/22/2017), 35354 (01/22/2017), 35355 (01/22/2017), 35458 (01/22/2017), 35474 (01/22/2017), 35487 (01/22/2017), 35492 (01/22/2017), 35561 (01/22/2017), 35565 (01/22/2017), 35568 (01/22/2017), 35603 (01/22/2017), 35614 (02/05/2017), 35615 (02/05/2017), 35617 (02/05/2017), 35618 (02/05/2017), 35624 (02/05/2017), 35625 (02/05/2017), 35634 (02/05/2017), 35705 (02/05/2017), 35706 (02/05/2017), 35767 (02/05/2017), 35771 (02/05/2017), 35774 (02/05/2017), 35795 (02/05/2017), 35797 (02/05/2017), 35801 (02/05/2017), 35807 (02/05/2017), 35826 (02/05/2017), 35856 (02/05/2017), 35857 (02/05/2017), 35862 (02/05/2017), 35864 (02/05/2017), 35887 (02/05/2017), 35888 (02/05/2017), 35890 (02/05/2017), 35891 (02/05/2017), 35900 (02/05/2017), 35904 (02/05/2017), 35905 (02/05/2017), 35906 (02/05/2017), 35908 (02/05/2017), 35909 (02/05/2017), 35910 (02/05/2017), 35911 (02/05/2017), 35913 (02/05/2017), 35914 (02/05/2017), 35915 (02/05/2017), 35926 (02/05/2017), 36060 (05/01/2017), 36067 (02/05/2017), 36068 (02/05/2017), 36073 (02/05/2017), 36082 (02/05/2017), 36084 (02/05/2017), 36085 (02/05/2017), 36090 (02/05/2017), 36132 (02/05/2017), 36140 (02/05/2017), 36141 (02/05/2017), 36143 (02/05/2017), 36151 (02/05/2017), 36983 (05/01/2017), 37596 (04/23/2017), 37873 (04/02/2017), 37882 (04/02/2017), 37883 (04/02/2017), 37917 (04/02/2017), 37929 (04/02/2017), 37973 (04/02/2017), 37978 (04/02/2017), 37979 (04/02/2017), 37980 (04/02/2017), 37982 (04/02/2017), 37983 (04/02/2017), 37986 (04/02/2017), 37991 (04/02/2017), 38048 (04/02/2017), 38052 (04/02/2017), 38061 (04/02/2017), 38102 (04/02/2017), 38130 (04/02/2017), 38139 (04/02/2017), (04/02/2017), 38141 (04/02/2017), 38150 (04/02/2017), 38156 (04/02/2017),  38160 (04/02/2017), 38187 (04/02/2017), 38220 (04/02/2017), 38227 (04/02/2017), 38232 (04/02/2017), 38242 (04/02/2017), 38247 (04/02/2017), 38250 (04/02/2017), 38257 (04/02/2017), 38262 (04/02/2017), 38267 (04/02/2017), 38269 (04/02/2017), 38271 (04/02/2017), 38281 (04/02/2017),  38286 (04/02/2017), 38287 (04/02/2017), 38291 (04/02/2017), 38294 (04/02/2017), 38300 (04/02/2017), 38305 (04/02/2017), 38309 (04/02/2017), 38311 (04/02/2017), 38316 (04/23/2017), 38328 (04/02/2017), 38331 (04/02/2017), 38333 (04/23/2017), 38413 (04/23/2017), 38423 (04/23/2017), 38433 (04/23/2017), 38442 (04/02/2017), 38454 (04/23/2017), 38455 (04/23/2017), 38460 (04/23/2017), 38461 (04/23/2017), 38467 (04/23/2017), 38468 (04/23/2017), 38469 (04/23/2017), 38470 (04/23/2017), 38472 (04/23/2017), 38474 (04/23/2017), 38480 (04/23/2017), 38488 (04/23/2017), 38492 (04/23/2017), 38495 (04/23/2017), 38496 (04/23/2017), 38500 (04/23/2017), 38502 (04/23/2017), 38503 (04/23/2017), 38504 (04/23/2017),  38509 (04/02/2017), 38518 (04/02/2017), 38519 (04/02/2017), 38527 (04/02/2017), 38528 (04/02/2017), 38531 (04/02/2017), 38533 (04/02/2017), 38555 (04/23/2017), 38562 (04/23/2017), 38571 (04/23/2017), 38601 (04/23/2017), 38619 (04/23/2017), 38634 (04/23/2017), 38636 (04/23/2017), 38649 (04/23/2017), 38653 (04/23/2017), 38654 (04/23/2017), 38656 (04/23/2017), 38658 (04/23/2017), 38659 (04/23/2017), 38660 (04/23/2017), 38663 (04/23/2017), 38666 (04/23/2017), 38673 (04/23/2017), 38677 (04/23/2017), 38678 (04/23/2017), 38680 (04/23/2017), 38681 (04/23/2017), 38682 (04/23/2017), 38683 (04/23/2017), 38684 (04/23/2017), 38686 (04/23/2017), 38690 (04/23/2017), 38694 (04/23/2017), 38695 (04/02/2017),  38696 (04/23/2017), 38697 (04/02/2017), 38699 (04/02/2017), 38701 (04/02/2017), 38704 (04/02/2017), 38705 (04/02/2017), 38706 (04/02/2017), 38707 (04/02/2017), 38708 (04/02/2017), 38709 (04/02/2017), 38710 (04/02/2017), 38711 (04/02/2017), 38715 (04/02/2017), 38721 (04/23/2017), 38723 (04/23/2017), (04/23/2017), 38724 (04/23/2017), 38726 (04/23/2017), 38727 (04/23/2017), 38728 (04/23/2017), 38729 (04/23/2017), 38731 (04/23/2017), 38733 (04/02/2017), 38734 (04/23/2017), 38736 (04/23/2017), 38737 (04/23/2017), 38738 (04/02/2017), 38739 (04/02/2017), 38740 (04/02/2017), 38741 (04/02/2017), 38743 (04/02/2017), 38748 (04/23/2017), 38749 (04/23/2017), 38750 (04/23/2017), 38757 (04/23/2017), 38763 (04/02/2017), 38764 (04/02/2017), 38765 (04/02/2017), 38767 (04/02/2017), 38776 (04/02/2017), 38778 (04/02/2017), 38780 (04/02/2017), 38781 (04/02/2017), 38788 (04/02/2017), 38790 (04/02/2017), 38796 (04/02/2017), 38798 (04/02/2017), 38799 (04/02/2017), 38806 (04/02/2017), 38807 (04/02/2017), 38810 (04/02/2017), 38835 (05/01/2017), 38841 (05/01/2017), 38844 (05/01/2017), 38847 (05/01/2017), 38848 (05/01/2017), 38856 (05/01/2017), 38858 (05/01/2017), 38859 (05/01/2017), 38862 (05/01/2017), 38863 (05/01/2017), 38864 (05/01/2017), 38867 (05/01/2017), 38868 (05/01/2017), 38869 (05/01/2017), 38877 (05/01/2017), 38880 (05/01/2017), 38881 (05/01/2017), 38882 (05/01/2017), 38883 (05/01/2017), 38884 (05/01/2017), 38886 (05/01/2017), 38887 (05/01/2017), 38888 (05/01/2017), 38891 (05/01/2017), 38892 (05/01/2017), 38894 (05/01/2017), 38896 (05/01/2017), 38897 (05/01/2017), 38901 (05/01/2017), 38902 (05/01/2017), 38904 (05/01/2017), 38905 (05/01/2017), 38909 (05/01/2017), 38912 (05/01/2017), 38915 (05/01/2017), 38918 (05/01/2017), 38920 (05/01/2017), 38924 (05/01/2017), 38925 (05/01/2017), 38928 (05/01/2017), 38930 (05/01/2017), 38931 (05/01/2017), 38934 (05/01/2017), 38936 (05/01/2017), 38941 (05/01/2017), 38942 (05/01/2017), 38943 (05/01/2017), 38944 (05/01/2017), 38946 (05/01/2017), 38947 (05/01/2017), 38948 (05/01/2017), 38954 (05/01/2017), 38957 (05/01/2017), 38958 (05/01/2017), 38959 (05/01/2017), 38961 (05/01/2017), 38965 (05/01/2017), 38966 (05/01/2017), 38968 (05/01/2017), 38970 (05/01/2017), 38971 (05/01/2017), 38973 (05/01/2017), 38974 (05/01/2017), 38976 (05/01/2017), 38982 (05/01/2017), 38983 (05/01/2017), 38984 (05/01/2017), 38989 (05/01/2017), 38994 (05/01/2017), 38999 (05/01/2017), 39000 (05/01/2017), 39003 (05/01/2017), 39004 (05/01/2017), 39008 (05/01/2017), 39009 (05/01/2017), 39010 (05/01/2017), 39014 (05/01/2017), 39015 (05/01/2017), 39016 (05/01/2017), 39017 (05/01/2017), 39019 (05/01/2017), 39022 (05/01/2017), 39027 (05/01/2017), 39028 (05/01/2017), 39030 (05/01/2017), 39038 (05/01/2017), 39039 (05/01/2017), 39041 (05/01/2017), 39045 (05/01/2017), 39048 (05/01/2017), 39055 (05/01/2017), 39071 (05/01/2017), 39073 (05/01/2017), 39093 (05/01/2017), 39095 (05/01/2017), 39096 (05/01/2017), 39098 (05/01/2017), 39099 (05/01/2017), 39100 (05/01/2017), 39102 (05/01/2017), 39103 (05/01/2017), 39109 (05/01/2017), 39110 (05/01/2017), 39118 (05/01/2017), (05/01/2017), 39154 (05/01/2017), 39157 (05/01/2017), (05/01/2017), 39169 (05/01/2017), 39192 (05/01/2017), 39197 (05/01/2017), 39198 (05/01/2017), 39199 (05/01/2017), 39200 (05/01/2017), 39202 (05/01/2017), 39209 (05/01/2017), 39211 (05/01/2017), 39216 (05/01/2017), 39217 (05/01/2017), 39218 (05/01/2017), 39220 (05/01/2017), 39230 (05/01/2017), 39231 (05/01/2017), 39234 (05/01/2017), 39243 (05/01/2017), 39269 (05/01/2017), 39270 (05/01/2017), 39289 (05/01/2017), 39292 (05/01/2017), 39300 (05/01/2017), 39315 (05/01/2017), 39318 (05/01/2017), 39326 (05/01/2017), 39329 (05/01/2017), 39330 (05/01/2017), 39331 (05/01/2017), 39332 (05/01/2017), 39333 (05/01/2017), 39337 (05/01/2017), 39338 (05/01/2017), 39343 (05/01/2017), 39345 (05/01/2017), 39346 (05/01/2017), 39348 (05/01/2017), 39350 (05/01/2017), 39352 (05/01/2017), 39355 (05/01/2017), 39357 (05/01/2017), 39359 (05/01/2017), 39360 (05/01/2017), 39361 (05/01/2017), 39363 (05/01/2017), 39365 (05/01/2017), 39366 (05/01/2017), 39367 (05/01/2017), 39369 (05/01/2017), 39373 (05/01/2017), 39374 (05/01/2017), 39377 (05/01/2017), 39409 (05/01/2017), 39438 (05/01/2017), 39441 (05/01/2017), 39442 (05/01/2017), 39445 (05/01/2017), 39446 (05/01/2017), 39449 (05/01/2017), 39452 (05/01/2017), 39453 (05/01/2017), 39454 (05/01/2017), 39507 (05/01/2017), 39509 (05/01/2017), 39679 (05/01/2017), 39684 (05/01/2017), 39686 (05/01/2017), 39691 (05/01/2017), 39715 (05/01/2017), 39732 (05/01/2017), 39734 (05/01/2017)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide and Puerto Rico and the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Puerto Rico. Distribution internationally to Argentina, Austria, Belgium, Canada, Croatia, Czech Republic, Finland, Germany, Ireland, Israel, Italy, Japan, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, United Arab Emirates, and United Kingdom.
  • 제품 설명
    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. || Product Usage: || United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • 제조사 모회사 (2017)
  • Source
    USFDA