PATCH

Description of Event or Problem

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED OUT OF RANGE HIGH SHOCK IMPEDANCES THROUGH THESE DEFIBRILLATION PATCHES. THERE WAS REPORT THAT DURING A CHANGE-OUT PROCEDURE THE PHYSICIAN HAD REPAIRED INSULATION ON ONE OF THE PATCHES. TECHNICAL SERVICES DISCUSSED OPTIONS AND TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. RESOLUTION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE. IT WAS LATER REPORTED THAT DEFIBRILLATION THRESHOLDS WERE TESTED AND THE SHOCK VECTOR WAS CHANGED WHICH RESOLVED THE IMPEDANCES.

Additional Manufacturer Narrative

INFORMATION SUGGESTS THESE PRODUCTS REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.