Events

Device Recall Infinity DBS IPG with MDT header 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St. Jude Medical, 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
    77509
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2694-2017
  • 사례 시작날짜
    2017-06-02
  • 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=156180
  • 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
    The firm discovered a risk of loss of neuromodulation therapy due to exposure of the ipg to monopolar electrosurgical devices (esu) during medical procedures.
  • 조치
    The notification material is in the form of a Physician Letter and Patient letter which will be delivered to physicians and patients in the US. The physician mailing will be initiated June 2, 2017 for delivery on June 7-9, 2017. The physicians were provided with patient management recommendations, Step for the patient controller updates, and Clinician's Manual Revised Warning. The Patient mailings will begin the week of June 12, 2017 to allow for clinician notification and are expected to be delivered within 3-5 business days. The patient letter informs of them of the potential for the loss of therapy and the steps to receive the software upgrade.

Device

Device Recall Infinity DBS IPG with MDT header
  • 모델명 / 제조번호(시리얼번호)
    ALX120.1 ALX227.1 ALY287.1 ALY390.1 ALY471.1 ALY534.1 ALY560.1 ALY668.1 ALZ030.1 AMN762.1 AMN904.1 AMN990.1 AMP134.1 AMP169.1 AMP189.1 AMP246.1 AMS702.1 AMT135.1 AMT160.1 AMT357.1 ANG915.1 ANG951.1 ZA3446.1 ZA3511.1 ZB0872.1 ZB1144.1 ZB1181.1 ZB1188.1 ZB1190.1 ZB1200.1 ZB1213.1 ZB1218.1 ZB1225.1 ZB1422.1 ZB1463.1 ZB1507.1 ZK3289.1 ZS0594.1 ZS0699.1 ZS0772.1 ZW0246.1 ZW0268.1 ZW0273.1 ZW0283.1 ZW0364.1 ZW8776.1 ZW8796.1 ZW8863.1 ZW8879.1 ZW8887.1 ZW8904.1 ZW8965.1 ZW8972.1 ZX5593.1
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO || Product Usage: || The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
  • Manufacturer
    St. Jude Medical, Inc.

Manufacturer

St. Jude Medical, Inc.
  • 제조사 주소
    St. Jude Medical, Inc., 6901 Preston Rd, Plano TX 75024-2508
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA