Related manufacturer report number: 2017865-2017-31367.During a follow-up, there were episodes of noise on the right ventricular (rv) channel.There were also episodes of inhibited pacing due to the noise episodes.While attempting to reprogram the device, it was difficult to interrogate and reprogram the device.The lead and the device were explanted and replaced and the patient was stable.
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Additional information: the device was received for evaluation and the device image showed about two hours of high power usage.Telemetry issue noted in the field is consistent with device normally switching to 8k telemetry mode, due to excessive high power usage, in order to preserve battery power.Analysis was performed; including thermal and mechanical revealed no anomalies.Visual inspection of septum, setscrew, and contact spring did not reveal any anomaly that could contribute to noise.Further analysis was performed to test for crosstalk and output monitoring indicated normal device performance.
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