CONFIRM

Description of Event or Problem

IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

Additional Manufacturer Narrative

THE REPORTED EVENT OF UNABLE TO INTERROGATE WAS CONFIRMED. THE REPORTED EVENT OF PREMATURE DISCHARGE OF BATTERY WAS NOT CONFIRMED. THE DEVICE WAS NOT ABLE TO BE INTERROGATED UPON RECEIPT DUE TO THE BATTERY VOLTAGE BEING AT END OF LIFE (EOL) LEVEL. ANALYSIS PERFORMED AFTER REPLACING WITH A NEW BATTERY DID NOT FIND ANY ANOMALY. THE CURRENT WAS WITHIN NORMAL RANGE. LONGEVITY ASSESSMENT WAS PERFORMED AND THE DEVICE MET THE PROJECTED LONGEVITY AND IS CONSIDERED NORMAL BATTERY DEPLETION.