Description of Event or Problem · 0
IT WAS REPORTED THAT THE RIGHT ATRIAL IRA) LEAD EXHIBITED OVER SENSED NOISY SIGNALS. THE PACING RATE ALSO WENT TO LOW VALUES CAUSING SYMPTOMS AS PALPITATIONS TO THE PATIENT. THESE SYMPTOMS HAVE BEEN PRESENT FOR A COUPLE OF YEARS. THE DEVICE WAS REPROGRAMMED AND THE PATIENT FELT WORSE. THE PATIENT IS VENTRICULAR PACING DEPENDENT BUT HAS AN UNDERLYING VENTRICULAR PACE OF 30 BPM. THERE WAS ALSO A RECORDED EPISODE WHERE NOISY SIGNALS ARE PRESENT WITH NORMAL SINUS RHYTHM, THEN THE DEVICE INHIBITS PACING AND THE RHYTHM REACHES A LOWER RATE. WHEN THE DEVICE INHIBITS PACING, NO MORE THAN 2 SECONDS OF INHIBITION WAS OBSERVED. TO DATE, THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).