LARGE PATCH DF-1 SUTURE UNI 67CM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED.

Additional Manufacturer Narrative

NOW SIX YEARS LATER, A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED SHOCK IMPEDANCES >125 OHMS ON THESE LEADS. NOISE IS STILL NOT PRESENT NOR COULD BE PRODUCED. THIS PATIENT HAS NOT GOTTEN DEFIBRILLATION THRESHOLD TESTINGS NOR HAS EVER RECEIVED A SHOCK. TECHNICAL SERVICES DISCUSSED CONFIGURATIONS TO DETERMINE WHICH PATCH MAY BE AFFECTED. IMPEDANCES THROUGH A SHOCK LEAD IMPEDANCE TEST (SLIT) RECORDED >125 OHMS AND 36 OHMS WITH A 1.1 JOULE SHOCK. AFTER THE SLIT THE IMPEDANCE LINGERED IN THE MID 40'S OHMS RANGE. THERE WAS INQUIRY OF WHY THE IMPEDANCE WOULD CHANGE AFTER A SHOCK DELIVERY. TECHNICAL SERVICES DISCUSSED THIS ISSUE FURTHER. INFORMATION SUGGESTS THE LEADS AND DEVICE REMAIN IN-SERVICE. THE PHYSICIAN IS ELECTING TO MONITOR THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED OTHER THAN THE PATIENT BEING HOSPITALIZED FOR A COUPLE OF DAYS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED. FURTHER INFORMATION HAS BEEN RECEIVED THAT THIS PATIENT HAD A VENTRICULAR TACHYCARDIA (VT) THAT WAS SUCCESSFULLY TREATED AND CONVERTED WITH A SHOCK IMPEDANCE ON 35 OHMS. THE PHYSICIAN THEN PERFORMED A SHOCK LEAD IMPEDANCE TEST AND GOT GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION WAS NOT AVAILABLE FROM THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE BUT EVIDENCE SUGGESTS THAT THIS RIGHT VENTRICULAR (RV) LEAD AND DEVICE REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem

BOSTON SCIENTIFIC(FORMERLY GUIDANT) RECEIVED INFORMATION THAT THESE EPICARDIAL HIGH VOLTAGE PATCH LEADS WERE EXHIBITING GRADUALLY INCREASING IMPEDANCE MEASUREMENTS PER LEAD INTEGRITY TESTS (LIT). THE SHOCK IMPEDANCE CONTINUED TO REMAIN WITHIN THE NORMAL RANGE. FURTHER INFORMATION NOTED THAT THE IMPEDANCES WERE RISING TO THE UPPER RANGE OF THE NORMAL LIMIT. NO NOISE WAS REPORTED. THE LEADS REMAINED IN-SERVICE. TECHNICAL SERVICES PROVIDED TROUBLESHOOTING RECOMMENDATIONS. IT WAS RECOMMENDED IF NOISE WAS NOT PRODUCED THE PHYSICIAN MAY EITHER REPLACE IT PROPHYLACTICALLY OR CONTINUE TO MONITOR UNTIL IMPEDANCE IS OUT OF NORMAL RANGE.