ANZCDACC Advisory Notice 4th December 2013

Australian and New Zealand Cardiac Device Advisory and Complications Committee (ANZCDACC)

Device: Reply and Esprit DR (Dual Chamber) and SR (Single Chamber) Pacemakers

Advisory Grade: Hazard Alert (Implanted Devices)

ANZCDACC Advisory Grade: Elective/Routine

Number in Australia: Approximately 1500 at risk

Description: Erroneous residual battery longevity displayed by pacemaker programmer. When the device approaches ERI, the overestimation of battery longevity could results in ERI or EOL being reached between follow up visits.

Advice: Frequent follow-up period recommendation has been changed: a maximum of 6 months follow-up interval when the battery impedance becomes greater or equal to 3.5 kΩ, instead of 5kΩ previously. This recommendation applies also after the correction. This Hazard Alert will be corrected in the new programmer software version (V2.4) which will be installed on all Sorin programmers (Orchestra and Orchestra Plus) within the next 3 months.