Evaluation summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated atrial oversensing.Analysis of the device memory indicated the impedance of the atrial pacing lead was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the atrial pacing lead was rising.If information is provided in the future, a supplemental report will be issued.
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It was reported that right atrial (ra) lead exhibited high, rising impedances, oversensing, and a polarity switch had occurred.The ra lead was reprogrammed and remains in use.No patient complications have been reported as a result of this event.
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