Events

Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Greatbatch Medical 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
    56324
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0287-2011
  • 사례 시작날짜
    2010-05-13
  • 사례 출판 날짜
    2010-11-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93235
  • 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
    Permanent pacemaker electrode - Product Code DTB
  • 원인
    The myopore bipolar epicardial leads packaging is labeled as unipolar leads. the lead body itself is correctly labeled as bipolar. this could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.
  • 조치
    Greatbatch Medical issued an Urgent Medical Device Recall letter dated May 13, 2010 to their distributor. The letter described the problem and product involved, and gave the action required which included: 1) immediately discontinue distribution of the units and return any unused units to Greatbatch Medical. 2) Reconcile medical recordsbetween BSC and Greatbatch Medical to confirm implant data 3) Confirm pulse generator type (bipoloar, unipolar, or unknown) used with each serial number listed Greatbatch will work with customers to contact physicians as necessary regarding patient monitoring. Greatbatch Medical can be contacted at 763-951-8312.

Device

Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead
  • 모델명 / 제조번호(시리얼번호)
    serial numbers: 123070, 123072, 123073, 123075 thru 123092, 123094, 123095, 123097 thru 123104, 123431, 123432, 123433.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: to USA and Europe, through distributor in MN.
  • 제품 설명
    enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • 제조사 주소
    Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
  • 제조사 모회사 (2017)
    Integer Holdings Corporation
  • Source
    USFDA