Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nuvectra 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
    73884
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1600-2016
  • 사례 시작날짜
    2016-04-06
  • 사례 출판 날짜
    2016-05-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-09-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, spinal-cord, totally implanted for pain relief - Product Code LGW
  • 원인
    If used, the optional swap feature copies programming parameters from the external pulse generator (epg) as well as unintended calibration data to the implantable pulse generator (lpg). this may result in the user being unable to recharge the lpg. this safety notice only applies to cps model 4500.
  • 조치
    Nuvectra sent an "Urgent Field Safety Notice" letter dated April 6, 2016 to customers. The letter identified the affected product, problem, recommendations and Mitigations, and actions to be taken.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial 000010 000011 FF0043 FF0045 000014 000015 000016 FF0054 FF0048 FF004B FF005D FF0064 FF0065 FF0067 FF00A9 FF00AD FF00BB   Lot  P178713 P185700 P187989 P195875 P213108 P257056
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Germany
  • 제품 설명
    Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. || The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient¿¿"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient¿¿"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient¿¿"s use of the system. || The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs
  • Manufacturer

Manufacturer

  • 제조사 주소
    Nuvectra, 10675 Naples St NE, Blaine MN 55449-5802
  • 제조사 모회사 (2017)
  • Source
    USFDA