Events

Recall of Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillator (ICDs) Affected devices implanted in Australia:Evera XT VR ICD

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia 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-2016-RN-01078-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01078-1
  • 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
    An issue has been identified with certain devices that were manufactured with a specific subset of circuit components. devices in the affected population may experience rapid battery depletion due to a low resistance path developing within the circuit component. development of a low resistance path in the circuit component in some cases has been reported to cause battery depletion in seven (7) days or less and may present clinically during a patient follow-up visit as:- one or more electrical resets, which will display as an observation on the programmer.- no pacing or defibrillation therapy output.- no telemetry.- programmer screen display of serious device memory failure.Patient audible alerts and carealerts may not reliably notify the patient or clinician. within these 78 devices there have been seven (7) confirmed failures (9%) through july 16, 2016. reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
  • Action
    Physicians are asked to advise patients to seek medical attention immediately if they experience symptoms (e.g., fainting or light-headedness) or if the audible patient alert sounds. For pacemaker-dependent patients or those at a higher risk of Ventricular Tachycardia or Ventricular Fibrillation, Physicians should consider device replacement. For other patients, Medtronic is recommending: · Program the audible alerts for “Low Battery Voltage RRT” to “On-High”. It is possible that alerts may not sound if the battery is depleted. Therefore physicians should also consider one of the following: - Provide a handheld magnet to patients to frequently check device status. - Prescribe either a CareLink transmission be performed by the patient, or a maintenance transmission by the clinic, on a more frequent basis (e.g., weekly or daily) based on the unique patient considerations. Medtronic is offering the above additional options at no cost.

Device

Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter...
  • Model / Serial
    Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillator (ICDs)Affected devices implanted in Australia:Evera XT VR ICD Model: DVBB2D4Serial numbers: BWJ601108S, BWJ601112S, BWJ601479S ARTG number: 208027
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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