Events

Recall of Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)

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-2017-RN-00493-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00493-1
  • 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
    Livanova has identified that in the event of a right ventricular lead issue (e.G. broken or disconnected lead), recurrent shock capacitor charging due to ventricular oversensing may result in depletion of the icd or crt-d battery. because the battery status is not updated for a 24-hour period following a charge, battery depletion may remain undetectable during the 24 hours following the last charge. recurrent charging will stop either after deactivation of the shock therapies, or when the oversensing stops, such as in the case of a lead revision. if an updated battery status is not obtained prior to the lead revision, the need for an icd or crt-d replacement cannot be assessed. if the battery is found to be depleted after the lead revision, adequate therapy may not be available and the patient may have to undergo another surgical procedure to replace the icd or crt-d.
  • Action
    LivaNova is advising surgeons who have decided to revise the right ventricular lead due to oversensing issues to take the following steps: 1. Prior to lead revision: a) Deactivate the shock therapies to avoid further charging These operations should be performed by medical personnel in an appropriate care unit, with resuscitation equipment present, and after having weighted the benefit/risks for the patient., b) Wait 24 hours1, and c) Re-interrogate the ICD or CRT-D to check the updated battery status. If RRT is reached, initiate a device replacement. Or 2. If it is not possible to wait 24 hours prior to replacing the lead, the lead revision may be performed as scheduled and the device may be replaced prophylactically during the same procedure since the battery status is unknown.

Device

Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardi...
  • Model / Serial
    Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Ovatio - CRT 6750, DR 6550, VR 6250Previous ARTG #: 132650, 132586, 132649 Paradym - VR 8250, DR 8550, CRT-D 8750ARTG #: 170105, 170104, 163470,Paradym RF - VR 9250, DR 9550, CRT-D 975, SonR 9770 ARTG #: 197571, 197572, 197573, 197574Intensia - VR 124, DR 154, CRT-D 174, SonR CRT-D 184ARTG #: 230583, 230582, 230580, 230581
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd