Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP VISIT, LOSS OF CAPTURE (LOC) WAS OBSERVED ON THE RIGHT ATRIAL (RA) CHANNEL. WHEN LDC WAS OBSERVED, HIGH IMPEDANCES OF 1900 OHMS WERE ALSO OBSERVED, AND THE PHYSICIAN WAS UNABLE TO VERIFY RIGHT ATRIUM PACING THRESHOLDS SINCE THE LEAD WAS NOT CAPTURING AT ANY OUTPUT. IT WAS NOTED THAT THE PATIENT FELT UNWELL WHEN ATRIAL LOC WAS OBSERVED. LOSS OF CAPTURE WAS NOT ALWAYS VISIBLE AND WAS ONLY VISIBLE AT THE BEGINNING OF THE INTERROGATION SESSION AND COULD NOT BE REPRODUCED BY HAVING THE PATIENT PERFORM POSTURAL MANEUVERS. NORMAL IMPEDANCES HAVE BEEN APPROXIMATELY BETWEEN 500 AND 600 OHMS, BUT INTERMITTENT JUMPS WERE VISIBLE IN THE RA IMPEDANCE TREND. NO NOISE COULD BE REPRODUCED BY THE PHYSICIAN WITH MANEUVERS OR POCKET MANIPULATION (TAPPING ON THE DEVICE). THE OUTPUT WAS TEMPORARILY PROGRAMMED TO 4VX 0.4 MS, BUT IT WAS NOT POSSIBLE TO CHECK THE CORRECT FUNCTIONING BECAUSE OF THE HIGH IMPEDANCES, WHICH WERE NO LONGER REPRODUCEABLE DURING THE FOLLOW-UP VISIT. AN ADDITIONAL FOLLOW-UP VISIT WAS PERFORMED, AND ALL PARAMETERS WERE STABLE AND WITHIN NORMAL RANGE. LOSS OF CAPTURE AND NOISE COULD NOT BE REPRODUCED WITH MANIPULATIONS OR MANEUVERS, AND THE IMPEDANCES WERE ALWAYS WITHIN RANGE. THIS LEAD REMAINS IMPLANTED AND 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).