Description of Event or Problem · 0
PREMATURE BATTERY DEPLETION OF THE PATIENTS GUARDIAN SYSTEM IMD RESULTED IN THE EXPLANT OF THE DEVICE ON (B)(6) 2023. THE INITIAL ISSUE OCCURRED (B)(6) 2022 WHEN THE PATIENT REPORTED TO HER DOCTOR WITH A SEE DOCTOR ALERT FROM THE DEVICE. AT THE DOCTOR'S OFFICE THE IMPLANT WAS INTERROGATED AND IT WAS DETERMINED THAT THE DEVICE HAD EXPERIENCED A DEVICE RESET. HOWEVER, THE DEVICE RECOVERED AND WAS WORKING CORRECTLY FOLLOWING THAT VISIT. THE PATIENT RETURNED TO THE CLINIC FOR A ROUTINE FOLLOW-UP VISIT ON (B)(6) 2022. AT THAT VISIT IT WAS DETERMINED THAT THE DEVICE COULD NO LONGER BE COMMUNICATED WITH VIA THE PROGRAMMER. THE PHYSICIAN WAS MADE AWARE OF THE ISSUE AND THE PHYSICIAN SPOKE TO THE PATIENT AT THAT TIME AND INDICATED THAT THE DEVICE SHOULD BE EXPLANTED IN ORDER TO PERFORM AN INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE PATIENT DECIDED TO HAVE THE DEVICE EXPLANTED AND REPLACED AND THAT PROCEDURE WAS PERFORMED ON (B)(6), 2023. THE DEVICE WAS DECONTAMINATED AND RETURNED TO AVERTIX FOR INVESTIGATION A WEEK LATER IN APRIL, 2023. THE FOLLOWING ISSUE WAS CREATED IN THE QMS OF AVERTIX FOR THIS PROBLEM: ISSUE 48 ISSUE 48 WAS ESCALATED TO A COMPLAINT FOR INVESTIGATION: COMPLAINT 36 COMPLAINT 36 WAS ASSIGNED TO CAPA FOR CORRECTIVE AND PREVENTIVE ACTION DETERMINATIONS: CAPA 12 THE PATIENT EXPERIENCED NO ADVERSE EVENTS ASSOCIATED WITH THE PROBLEM OR THE EXPLANT PROCEDURE.