ANZCDACC Advisory Notice 24th May 2017

Device:  LivaNova  Ovatio, Paradym RF and Intensia ICD’s and CRT’s

TGA Ref: RC-2017-RN-004393-1

Advisory Grade TGA: Class II Recall

ANZDACC Advisory Grade: Routine

Description: Undetectable battery depletion in the event of recurrent shocks or capacitor charge due to defibrillator lead issue/failure (over sensing, disconnected or broken defibrillator leads) where an intervention is planned on the defibrillator lead within 24 hours.

Risk: Can occur in any of the above mentioned devices where battery function is checked within 24 hours of recurrent shock capacitor charges in the event of defibrillator lead issue/failure.

Number of devices affected in Australia and New Zealand: TBA in Australia Zero in New Zealand: not supplied.

Presentation: Patient’s that have recurrent shock capacitor charges (due to defibrillator lead issue/failure) with the affected device are at risk of unreliable battery assessment. Battery measurements within 24 hours of last capacitor charge will not be updated and therefore may be inaccurate resulting in failure of detection of RRT status. Battery status is updated 24 hours after last shock capacitor charge and will represent accurate battery measurement. Lead integrity alerts and lead over sensing episodes are indicative of patients at risk recurrent shock capacitor charges and as such at risk of this advisory.

Advice: Patient’s that present with either appropriate or inappropriate recurrent shock capacitor charges who have a device interrogation within 24 hours of the last capacitor charge must have an additional integration 24 hours after the last capacitor charge to ensure accurate battery estimate.

For patients that present with lead integrity issues and recurrent shock capacitor charge requiring lead revision, it is recommended that the ICD tachycardia therapies are deactivated and the patient externally monitored 24 hours prior to intervention with revaluation of battery status after the 24 hour period has elapsed, and prior to lead revision to confirm battery status.

Where lead intervention is required before 24 hours of last shock capacitor charge then the physician should consider prophylactic ICD generator change at time of lead revision. In this situation if the ICD generator is not changed then the patient will require a device interrogation 24 hours after last shock capacitor charge.

Devices that do not have recurrent shock capacitor charges do not require any intervention or increased follow up. These should undergo usual clinical follow-up.