Events

Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and RestoreSensor Implantable Spinal Cord Stimulators 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia Pty Ltd 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
    RC-2014-RN-00041-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-01-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00041-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    1) unexpected loss of stimulation may occur under the following conditions:- switching from a group with two programs to a group with three or four programs where a non-negative contact is shared within the programmed groups. - creating program groups (activa sc only) when a second program is created for the first time.2) under a specific set of conditions (activa sc – models 37602 / 37603 are not affected), typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended:- device reaches a power on reset (por) state. a por may be detected during interrogation with the patient or physician programmer. the patient will experience loss of therapy if a por occurs.- ‘therapy off’ command is sent (by patient programmer, insr, or ‘therapy-stop’ button on the 8840 clinician programmer) to device while the device is making an automatic periodic battery measurement.
  • 조치
    Medtronic does not recommend prophylactic explant of devices because these issues can be addressed non-invasively by the clinician using an 8840 clinician programmer or an Implantable Neurostimulator Recharger using the Physician Recharge Mode. The model 8870 software application card used by the programmer is being updated to version BBR01A by Medtronic field representative. Interrogating patient’s device with the updated software version will automatically update the implanted device software and reduce the probability that a loss of stimulation output will occur. To significantly reduce the likelihood of over stimulation or stimulation in the wrong area, patients should avoid over discharge. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-deep-brain-spinal-cord-stimulation-devices-140204.htm . Thia action has been closed-out on 28/01/2016.

Device

Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and Restor...
  • 모델명 / 제조번호(시리얼번호)
    Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and RestoreSensor Implantable Spinal Cord StimulatorsActiva PC, Activa RC and Activa SC Implantable Deep Brain StimulatorsModel Numbers: 37601, 37602, 37603, 37612ARTG Numbers: 160118, 188274, 188034, 160117 RestoreUltra and RestoreSensor Implantable Spinal Cord StimulatorsModel Numbers: 37712, 37714ARTG Numbers: 154866, 177594
  • 의료기기 분류등급
    Neurological Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA