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Patient 1
THE DEVICE WAS RECEIVED FOR ANALYSIS. PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS DEVICE WERE RE-INVESTIGATED AND ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. DURING INITIAL DEVICE INTERROGATION A WARNING MESSAGE WAS TRIGGERED REGARDING THE BATTERY CONDITION, AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE BATTERY STATUS WAS ERI, WHICH WAS DETECTED ON (B)(6) 2018. THE MEMORY CONTENT DOCUMENTED A NORMAL AND EXPECTED CURRENT CONSUMPTION, HOWEVER, AN INCONSISTENCY BETWEEN CURRENT CONSUMPTION AND BATTERY VOLTAGE WAS NOTED. THEREFORE THE DEVICE WAS OPENED AND SUBJECTED TO FURTHER INVESTIGATION. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. THE MEASUREMENT OF THE BATTERY VOLTAGE CONFIRMED A DEPLETED BATTERY. NEXT, THE BATTERY WAS DISCONNECTED FROM THE ELECTRONIC MODULE. FURTHER THOROUGH INVESTIGATION OF THE ELECTRONIC MODULE DID NOT SHOW ANY ANOMALIES. IN PARTICULAR THE CURRENT CONSUMPTION PROVED TO BE NORMAL AND EXPECTED. THE BATTERY WAS SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS. THE MANUFACTURING RECORDS OF THE BATTERY WERE INSPECTED, DOCUMENTING THAT THE BATTERY PARAMETERS WERE WITHIN SPECIFICATION DURING THE MANUFACTURING. NO ANOMALIES WERE DOCUMENTED DURING THE PRODUCTION PROCESS, ASSOCIATED WITH THIS BATTERY. THE BATTERY WAS SUBJECTED TO A VISUAL AND AN ELECTRICAL INSPECTION AS WELL AS A MICROCALORIMETRY ANALYSIS. THE VISUAL INSPECTION OF THE BATTERY DID NOT REVEAL ANY EXTERNAL SIGNS OF DAMAGE. THE MEASUREMENT OF THE BATTERY VOLTAGE CONFIRMED A DEPLETED BATTERY. THE MICROCALORIMETRY ANALYSIS DID NOT SHOW ANY ANOMALIES. NEXT, THE BATTERY WAS OPENED FOR DESTRUCTIVE ANALYSIS. THE INSPECTION OF THE INNER ASSEMBLY IDENTIFIED DAMAGED INSULATION, WHICH LED TO AN ELEVATED INTERNAL SELF-DEPLETION WITHIN THE BATTERY AND THEREFORE CONTRIBUTED TO THE CLINICAL OBSERVATION. IN CONCLUSION, AN ELEVATED INTERNAL SELF-DEPLETION WITHIN THE BATTERY WAS FOUND TO BE THE ROOT CAUSE FOR THE CLINICAL OBSERVATION.