| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01078-1 |
| Product Name/Description |
Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillator (ICDs)
Affected devices implanted in Australia:
Evera XT VR ICD
Model: DVBB2D4
Serial numbers: BWJ601108S, BWJ601112S, BWJ601479S
ARTG number: 208027 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
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.
This action has been closed out on the 26/09/2018. |
| Contact Information |
02 9857 9052 - Medtronic Australasia |