It was reported that this patient underwent two sessions of lung radiation after which there was loss of capture on the right ventricular (rv) channel.The patient's electrophysiologist recommended the patient cease radiation; however, the patient went against the physician's wishes and underwent another radiation session.Two days later, the patient presented with weakness and a low pulse.The patient was then admitted to the cardiac care unit (ccu) and the monitoring strip showed some supposed pacing spikes with thirty second loss of capture.Threshold measurements have remained stable; however, pacing impedance measurements have been increasing since the therapy and was most recently 873 ohms.A download of the device data was performed and was evaluated by a boston scientific engineer who confirmed the device is functioning appropriately.A revision procedure was performed and the system was explanted and a system upgrade was performed.No additional adverse patient effects were reported.
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Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
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