MEDTRONIC

Description of Event or Problem

ELECTIVE PACER BATTERY REPLACEMENT DUE TO BATTERY DEPLETION. PACEMAKER INTERMITTENTLY NOT CAPTURING. REPLACED BY PULSE GENERATOR. LEADS ALSO REPLACED. REPLACED LEADS WERE CAPPEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: EARLY EOL, RRT INDICATOR - END OF LIFE. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.