Description of Event or Problem · 1
IT WAS REPORTED A PT UNDERWENT GENERATOR REVISION SURGERY DUE TO END OF SERVICE. DURING SURGERY, THE PHYSICIAN COULD NOT ESTABLISH COMMUNICATION WITH THE PT'S GENERATOR DUE TO END OF SERVICE. THE GENERATOR WAS EXPLANTED AND REPLACED. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR DEVICE EVAL. DURING ANALYSIS, IT WAS FOUND THAT THE C6 AND C15 CAPACITORS DID NOT MEET THE FUNCTIONAL SPECIFICATIONS. THESE MEASUREMENTS DEMONSTRATE AN INCREASED CURRENT CONSUMPTION FOR THE DEVICE. THE C15 CAPACITOR FUNCTIONS AS A DECOUPLING CAPACITOR AND DOES NOT AFFECT THE SUPPLY CURRENT THAT WOULD CONTRIBUTE TO BATTERY DEPLETION. HOWEVER, RESULTS OF THE LONGEVITY PREDICTION CONFIRM THAT THE GENERATOR WAS APPROACHING THE ELECTIVE REPLACEMENT INDICATOR, -0.64 YEARS TO ERI. AS A RESULT, THE EXTENT TO WHICH THE C6 CAPACITOR MAY HAVE CONTRIBUTED TO THE END-OF-SERVICE CONDITION CANNOT BE DETERMINED. CAUSE FOR THE C6 & C15 CAPACITORS INCREASE IN LEAKAGE COULD NOT BE DETERMINED. WITH THE CAPACITOR SUBSTITUTION FOR C6 & C15, THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE DHR FOR THE GENERATOR WAS REVIEWED AND PROPER DEVICE FUNCTION PRIOR TO SHIPMENT WAS CONFIRMED.