PATCH

Additional Manufacturer Narrative

IN TROUBLESHOOTING, THE PHYSICIAN DID DO A COMMANDED SHOCK AFTER WHICH TIME SHOCK IMPEDANCE WAS ONCE AGAIN WITHIN NORMAL RANGE. THE PHYSICIAN SUSPECTED THAT CALCIFICATION ON THE LEAD TIP HAD BURNED OFF. THEN, MOST RECENTLY, SHOCK IMPEDANCE WAS VARIANT AGAIN, ALTHOUGH NEVER OUT-OF-RANGE. THE PHYSICIAN ELECTED TO SURGICALLY ABANDONED THIS RV LEAD AND EXPLANT THE ICD, WHICH IS PLANNED FOR RETURN TO BOSTON SCIENTIFIC.

Description of Event or Problem

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID EXHIBIT VARIANCE IN SHOCK IMPEDANCE MEASUREMENTS. A CONDUCTOR ISSUE WAS SUSPECTED DUE TO THE AGE OF THE LEAD. HOWEVER, AT THE TIME OF THIS INITIAL REPORT, FURTHER TROUBLESHOOTING HAD NOT YET BEEN DONE. A MAXIMUM ENERGY SHOCK HAD NOT BEEN DONE TO TEST THE INTEGRITY OF THE DEVICE SYSTEM. THE SOURCE OF THE ISSUE WAS NOT YET KNOWN. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.