Description of Event or Problem · 0
DURING A ROUTINE 18-MONTH PATIENT FOLLOW-UP VISIT ON JUNE 6, 2024, THE PATIENT INFORMED THE IMPULSE DYNAMICS (ID) REPRESENTATIVE THAT THEIR CHARGER HAD NOT BEEN WORKING SINCE THEIR LAST FOLLOW-UP VISIT 6 MONTHS PRIOR. THE REP CONFIRMED THE PATIENT'S CHARGER DID INDEED HAVE A DEPLETED BATTERY AND BEGAN CHARGING THE CHARGER. THE REP ATTEMPTED TO INTERROGATE THE PATIENT'S OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG), BUT THE DEVICE COULD NOT BE INTERROGATED DUE TO LOW BATTERY. MULTIPLE ATTEMPTS TO CHARGE THE DEVICE RESULTED IN A TEMPERATURE ERROR DISPLAYING ON THE CHARGER AFTER VARIOUS PERIODS OF TIME ANYWHERE FROM 1 O MINUTES TO ONLY A FEW SECONDS. THE IPG WAS ABLE TO BE CHARGED SUFFICIENTLY FOR THE REP TO INTERROGATE THE DEVICE, WHICH YIELDED A "TELEMET ERROR: DOWN_ TEMP _INTEGRITY 3" ERROR. AFTER IMMEDIATE REVIEW OF THE DEVICE LOG FILES BY MEMBERS OF THE ID TECHNICAL OPERATIONS AND PRODUCT DEVELOPMENT TEAMS, THE REP WAS INSTRUCTED TO WAIT 20 MINUTES FOR THE IPG THERMOSTAT TO RESET ITSELF BEFORE CHARGING WAS INITIATED AGAIN. EVEN AFTER FOLLOWING THIS INSTRUCTION, THE SAME TEMPERATURE ERROR PERSISTED WHEN CHARGING THE IPG WAS ATTEMPTED. ANALYSIS OF THE IPG LOG FILES POINT TO PRELIMINARY EVIDENCE OF AN IPG HARDWARE PROBLEM. HOWEVER, THIS IS NOT POSSIBLE TO CONFIRM UNTIL A FULL EVALUATION OF THE DEVICE IS CONDUCTED. BASED ON THIS, ID REPRESENTATIVES HAVE MET WITH THE IMPLANTING PHYSICIAN, WHO WILL THEN MEET WITH THE PATIENT IN THE COMING WEEKS TO SEE IF THEY ARE WILLING TO HAVE THEIR IPG REPLACED. IT IS EXPECTED THAT THIS DEVICE WILL BE EXPLANTED AND REPLACED, BUT A REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME.