Events

Device Recall RestoreUltra and RestoreSensor 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
    66841
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1524-2014
  • 사례 시작날짜
    2014-02-27
  • 사례 출판 날짜
    2014-04-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123720
  • 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
    Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. the use of this feature is determined by the physician and set using the clinician programmer. current labeling indicates the use of cycling improves device longevity and recharge interval.
  • 조치
    Medtronic sent a Medical Device Correction letter dated February 2014 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: If you have patients with cycling enabled or wish to use cycling, use the updated calculations and graphs available online at professional.medtronic.com/cycling to assess the impact of cycling on device longevity. Medtronic will update the product labeling in the second half of 2014. " Remind your patients to continue to check their battery status. Instructions on how to check battery status can be found in the patient programmer or recharger system manual. " Pain Stimulation Trialing Only: The cycling feature should not be enabled on the External Neurostimulator (ENS) when estimating device longevity because the resulting longevity estimate for non-rechargeable devices may not provide accurate information. Consignees were also instructed to acknowledge receipt of the notice by completing the attached reply form and returning it to Medtronic using the contact details on the reply form. For questions consignees can contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7am - 6pm CST. For questions regarding this recall call 800-707-0933.

Device

Device Recall RestoreUltra and RestoreSensor
  • 모델명 / 제조번호(시리얼번호)
    The first released affected product was released to the market in April, 2005.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - all states including DC and Puerto Rico.
  • 제품 설명
    Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • 제조사 주소
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA