Events

Myopore 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
    53777
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0581-2010
  • 사례 시작날짜
    2009-09-01
  • 사례 출판 날짜
    2009-12-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86499
  • 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
    Bipolar pacing lead, permanent pacemaker electrode - Product Code DTB
  • 원인
    The silicone tubing of affected leads was processed outside of validated parameters. although the material remains biocompatible, test data regarding the performance characteristics are not available.
  • 조치
    Customers were contacted by phone beginning 09/01/09. They were asked to hold product and determine if they had distributed any product. A written notification followed which identified the product, described the issue and asked for product to be returned. Product was distributed to two consignees and contained the following day. Questions are directed to the company at 612-559-2613.

Device

Myopore sutureless Myocardial Pacing Lead
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 148399, 148400, 148401, 148402, 148403, 148404, 148405, 148406, 148407, 148408, 148409, 148410, 148411, 148412, 148413, 148414, 148415, 148416, 148417, 148418, 148419, 148420, 148421, 148422, 148423,  148424, 148427, 148430, 148431, 148433, 148434, 148435, 148436, 148437, 148438.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    CA and MN
  • 제품 설명
    Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner 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