ELECTRODE, PACEMAKER, TEMPORARY

Description of Event or Problem

IT WAS REPORTED THAT THIS UNKNOWN TEMPORARY PACING WIRE WAS PLACED DUE TO NON-CAPTURE ON THE CHRONIC LEAD. OUTPUT WAS ADJUSTED AND THE DEVICE WAS TURNED OFF AT 3AM DUE TO INTERFERING WITH THE TEMPORARY PACING WIRE. IT WAS SUSPECTED THAT THE DELIVERED ENERGY FROM THE CHRONIC RV LEAD RESULTED IN OVERSENSING, PACING INHIBITION, AND PAUSES ON THE MONITOR FOR THE TEMPORARY PACING WIRE. SUBSEQUENTLY, THE TEMPORARY PACING WIRE WAS REMOVED DURING THE RV LEAD REVISION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIELD REPRESENTATIVE PROVIDED A CORRECTION NOTING THE PATIENT HAD A SUCCESSFUL BYPASS PROCEDURE, NOT A HEART TRANSPLANT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MODEL/SERIAL NUMBER OF THE TEMPORARY PACING WIRE HAVE OCCURRED WITHOUT SUCCESS. AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED. ADDITIONALLY, IT WAS SUSPECTED THE TEMPORARY PACING WIRE WAS DISCARDED AFTER REMOVAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).