ANZCDACC Advisory Notice 21st August 2014

Device: St Jude Ellipse VR and DR Implantable Cardioverter Defibrillators Model Nos.: CD1277 ( ‐ 36 and ‐ 36Q), CD1377 ( ‐ 36, ‐ 36Q, ‐ 36C and ‐ 36QC), CD2277 ( ‐ 36 and ‐ 36Q), CD2377 ( ‐ 36, ‐ 36Q, ‐ 36C and ‐ 36QC) Advisory Grade TGA: Class I Hazard Alert (Implanted devices) and Recall (Devices on shelves)

ANZDACC Advisory Grade: Semi Urgent

Number: Approximately 47,000 at risk worldwide

Risk: Approximately 0.47% . There have currently been 179 incidences of the event worldwide

Description: St Jude has identified extended charge times for delivery of defibrillation due to “internal damage” to the capacitors involved in the high voltage circuitry. The usual charge time is approximately 15 seconds. With this anomaly the device will deliver a shock at 32 seconds irrespective of the energy from the charge and as such a clinically ineffective shock may be given. Once this has occurred the capacitors recover normally to deliver subsequent normal charges in all clinical episodes so far. The anomaly may also occur during capacitor maintenance or charging such as during a Defibrillation Threshold Test.

Presentation: Advisory can present with “vibratory alert” due to prolonged charge times during capacitor maintenance (most common) or prolonged times to defibrillation during cardiac arrest (other than defibrillation threshold testing this has not been observed currently clinically)

Advice: All patients with this device should be considered for home monitoring where feasible to assess for capacitor anomalies (extend charge time) and enable early detection of the anomaly. Devices with this problem should have consideration for their capacitor maintenance interval to be programmed to 4 monthly (instead of 6 monthly). This will however incur approximately 9 month decrease in battery longevity .

If a patient has received a “vibratory alert” and/or if a programmer or home monitoring has detected an extended charge time: Review the patient in person and interrogate the device and perform a manual capacitor maintenance charge ASAP. Normal charge time is 15 seconds or less. The results should be reviewed with your St. Jude Medical representative to discuss if additional evaluation is required. A device that has experienced repeated extended charge time out warnings should be considered for replacement. Otherwise usual surveillance is satisfactory (3 ‐ 6 monthly).