Events

Recall of Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by LivaNova Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00929-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-07-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00929-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    On a subset of platinium icd and crt-d devices, a specific hardware configuration was identified as potentially defective over time, leading to overconsumption, immediately followed by loss of pacing and sensing capabilities in all cavities. as a result of the loss of sensing capability, the device cannot identify an arrhythmia that would require a defibrillation shock therapy.No permanent injury or death has been reported as a result of this issue.
  • Action
    Microport CRM is initiating a removal of the non-implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients; and In order to mitigate the potential risks associated with the loss of the device pacing and sensing capabilities, Microport CRM recommends physicians follow-up the patients at the periodicity already stated in the implant manual.

Device

Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CR...
  • Model / Serial
    Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)PLATINIUM VR 1210ARTG No: 282817PLATINIUM VR 1240ARTG No: 282816PLATINIUM DR 1510ARTG No: 282818PLATINIUM DR 1540ARTG No: 282819PLATINIUM CRT-D 1711ARTG No: 282820PLATINIUM CRT-D 1741ARTG No: 282821PLATINIUM SONR CRT-D 1811ARTG No: 282822PLATINIUM SONR CRT-D 1841ARTG No: 282823
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd