ISOLINE

Description of Event or Problem

IT WAS REPORTED THAT WHILE CLOSING THE POCKET DURING A ROUTINE DEVICE REVISION, THIS NEWLY IMPLANTED DEVICE SHOWED A HIGH OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENT OF GREATER THAN 200 OHMS ON THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED AFTER THE RV LEAD WAS CONNECTED TO THE NEW DEVICE THE SHOCK LEAD IMPEDANCE MEASUREMENT RANGED FROM 80 TO 200 OHMS WITH NOISE OBSERVED. THE PACING MEASUREMENTS WERE ALL SATISFACTORY. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOOTING AND RECOMMENDATIONS FOR DEVICE AND LEAD ASSESSMENTS. THE PHYSICIAN ELECTED TO CAP AND SURGICALLY ABANDON THE RV LEAD AND REPLACE IT WITH ANOTHER NON-BOSTON SCIENTIFIC RV LEAD. THE NEW IMPLANTED RV LEAD EXHIBITED APPROPRIATE IMPEDANCE MEASUREMENTS WITH NO NOISE OBSERVED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Additional Manufacturer Narrative

AS NO INFORMATION WAS PROVIDED AND AS THE SERIAL NUMBER OF THE LEAD IS UNKNOWN AND THE LEAD IS NOT RETURNED TO BE ANALYSIS, NO CONCLUSION COULD BE ESTABLISHED. THE EVENT IS RECOVERED IN OUR DATABASE FOR TRENDS PURPOSES.