Events

Device Recall iCon Patient Programmer 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
    48752
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2322-2008
  • 사례 시작날짜
    2008-05-12
  • 사례 출판 날짜
    2008-09-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72059
  • 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, implantable, for incontinence - Product Code EZW
  • 원인
    Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. the application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.
  • 조치
    A letter was sent to each account telling them of the issue and to let them know that Medtronic is retrieving the affected devices. Medtronic Reps were to visit affected accounts to notify them of the recall, locate the affected device and return it. Rep is to complete the reply card and fax to Medtronic Neuromodulation. If you have questions, contact your Medtronic representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Device

Device Recall iCon Patient Programmer
  • 모델명 / 제조번호(시리얼번호)
    serial numbers: NJD058707N, NJD062024N, NJD063259N, and NJD063324N
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    GA, MO, NC, TX no OUS distribution
  • 제품 설명
    Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • 제조사 주소
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA