Events

Recharger 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Neuromodulation 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
    75458
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0700-2017
  • 사례 시작날짜
    2016-10-03
  • 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=150430
  • 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, electrical, implanted, for parkinsonian tremor - Product Code MHY
  • 원인
    Medtronic has identified an increased number of complaints from customers involving reports of rechargers (medtronic model 37751 recharger, which is included in models 37754 and 97754 charging systems,spinal cord stimulation)that are in an unresponsive error state, where the recharger is non-functional with a blank display screen and is beeping every 5 seconds. medtronic has determined all rechargers manufactured starting in november 2014 (indicated by serial numbers beginning with nka4 or nku4) are more susceptible to this error state.
  • 조치
    Consignees were sent a series of documents which included an introductory Medtronic and "Urgent Medical Device Correction" letters dated September 2016. The urgent letters included one for Deep Brain Stimulation (DBS) and one for Spinal Cord Stimulation(SCS) . Each letter was addressed to Healthcare Professional. Only physicians associated with both SCS and DBS therapy received the cover letter. The letters provided information on "Background, Issues Mitigation, Recommendation, Additional Information and Patient Notification (DBS). Requested consignees to complete and return the Physician /HCP Reply Form. For questions contact Medtronic Technical Services at 1-800-707-0933 weekdays 7 am to 6pm, CT.

Device

Recharger
  • 모델명 / 제조번호(시리얼번호)
    serial numbers beginning with NKA4 or NKU4
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide including DC OUS: Canada and others.
  • 제품 설명
    Model 37751 Recharger || Product Usage: || The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an AC power supply and power cord (Model 37761) and an antenna.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • 제조사 주소
    Medtronic Neuromodulation, 7000 Central Ave, Minneapolis MN 55421-1241
  • 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