Description of Event or Problem · 0
DURING A ROUTINE OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT PROCEDURE ON (B)(6) 2024, THE PATIENT EXPERIENCED AN ATRIAL ARRHYTHMIA AFTER THE IMPLANT POCKET HAD BEEN CLOSED BUT WHILE STILL ON THE OPERATING TABLE. THE PHYSICIAN PERFORMED A CARDIOVERSION THAT SUCCESSFULLY TERMINATED THE ARRHYTHMIA. SHORTLY AFTER THIS WAS PERFORMED, CONNECTION TO THE IPG SITTING INSIDE THE POCKET WAS LOST. ATTEMPTS TO INTERROGATE THE IPG WERE UNSUCCESSFUL, EVEN AFTER THE BANDAGES AROUND THE POCKET WERE REMOVED. ATTEMPTS TO BLIND-CHARGE THE DEVICE WERE EQUALLY UNSUCCESSFUL. NO WIRELESS CONNECTION COULD BE ESTABLISHED WITH THE IPG. THE PHYSICIAN AT THIS TIME MADE THE DECISION TO SWAP THE IPG ALREADY IMPLANTED IN THE PATIENT. THE POCKET WAS REOPENED AND THE IMPLANTED IPG WAS REMOVED AND DISCONNECTED FROM THE LEADS. THE NEW IPG WAS CONNECTED TO THE LEADS, PLACED IN THE POCKET, AND FUNCTIONED AS NORMAL. SUBSEQUENT POSTOPERATIVE CHECKS HAVE CONFIRMED NORMAL DEVICE FUNCTIONALITY, AND THE PATIENT HAS NOT REPORTED ANY PROBLEMS WITH THEIR DEVICE. THE NONFUNCTIONAL IPG WAS SHIPPED BACK TO IMPULSE DYNAMICS USA FOR INITIAL EVALUATION ON JULY 11 , 2024. INITIAL ATTEMPTS TO INTERROGATE OR CHARGE THE DEVICE WITHIN THE PROTECTIVE, SEALED BAG WERE UNSUCCESSFUL. THE DEVICE WAS UNABLE TO UNDERGO ELECTRONIC CONTROLS TESTING SINCE IT COULD NOT BE POWERED ON NOR COULD ANY CONNECTION WITH THE DEVICE BE ESTABLISHED. NO VISUAL SIGNS OF DAMAGE WERE OBSERVED. AFTER THE DEVICE WAS SENT OUT AND RETURNED FROM DECONTAMINATION AT AN APPROVED DECONTAMINATION FACILITY ON JULY 22, 2024, A MORE IN-DEPTH EVALUATION BEGAN. THIS EVALUATION REVEALED THE CAUSE OF THE MALFUNCTION WAS A BLOWN FUSE. ALTHOUGH THE HIGH LEVEL OF ENERGY DELIVERED DURING CARDIOVERSION CAN BE ENOUGH TO BLOW A FUSE IN AN IPG, THE ROOT CAUSE OF THIS BLOWN FUSE IS STILL UNDER INVESTIGATION AT THE TIME OF THIS FILING.