It was reported that there was difficulty interrogating this device.The initial interrogation was successful.While getting the atrial fibrillation episodes, the interrogation stopped.The programmer was rebooted, and the follow-up was successful.Later, this occurred again.The pulse generator remains implanted but the programmer will be returned.There were no adverse patient effects.
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited telemetry difficulty issues with no conclusive evidence of a malfunction; please refer to the event description for more information regarding the specific circumstances of this event.
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