PERMANENT PACEMAKER ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT A REQUEST WAS MADE TO HAVE DATA FROM THIS PACEMAKER SYSTEM REVIEW DUE TO AN ATRIAL TACHY RESPONSE (ATR) EPISODE. TECHNICAL SERVICES (TS) WAS CONSULTED, AND UPON DATA REVIEW, DISCUSSED THAT THERE HAD BEEN FARFIELD OVERSENSING OF A VENTRICULAR PACING EVENT. WHILE ON CALL, TS RECOMMENDED REPROGRAMMING CONFIGURATIONS, WHICH RESOLVED THE PROBLEM. IN ADDITION, NOISY ARTIFACT SIGNALS WERE NOTED. THEREFORE, ISOMETRIC AND POCKET EVALUATION, ALONG WITH IMPEDANCE TESTING, WERE ALSO RECOMMENDED. THIS NON BSC RIGHT ATRIAL (RA) LEAD 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).