| Product Name/Description |
Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
Ovatio - CRT 6750, DR 6550, VR 6250
Previous ARTG #: 132650, 132586, 132649
Paradym - VR 8250, DR 8550, CRT-D 8750
ARTG #: 170105, 170104, 163470,
Paradym RF - VR 9250, DR 9550, CRT-D 975, SonR 9770
ARTG #: 197571, 197572, 197573, 197574
Intensia - VR 124, DR 154, CRT-D 174, SonR CRT-D 184
ARTG #: 230583, 230582, 230580, 230581 |
| Reason/Issue |
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. |
| Recall Action Instructions |
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.
This action has been closed out on the 09/10/2018. |