RV LEAD

Description of Event or Problem

IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD NOISE WAS OBSERVED. AN INCREASE IN STORED EVENTS DUE TO NOISE ISSUES WAS ALSO OBSERVED. IN-CLINIC PROVOCATIVE MANEUVERS REPRODUCED NOISE ON THE VENTRICULAR CHANNEL BUT MOST OF THEM WERE NOT SENSED BY THE DEVICE. IT WAS NOTED THE PATIENT PARTICIPATES IN ROCK CLIMBING ACTIVITIES WHICH HE HAS BEEN ASKED TO STOP FOR NOW. TECHNICAL SERVICES (TS) WAS CONSULTED AND CONFIRMED THE PRESENCE OF NON-CARDIAC, HIGH FREQUENCY SIGNALS ON THE LEAD. IN BIPOLAR LEAD CONFIGURATION THIS INDICATES A MECHANICAL LEAD INTEGRITY ISSUE. THESE BEHAVIORS ARE PROGRESSIVE IN NATURE WHICH IS WHAT CURRENTLY IS BEING OBSERVED BY AN INCREASE IN EVENTS. AS SUCH, LEAD REVISION WAS RECOMMENDED. AT THIS TIME, THERE IS NO EVIDENCE INTERVENTION HAS BEEN PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).