Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensed noise on the right ventricular (rv) channel.The patient received 16 inappropriate shocks, so this crt-d was programmed off.However, the physician then elected to place a magnet over the device instead to avoid more inappropriate shocks until a revision could occur.Low out of range pace impedances of less than 200 ohms had also been observed.The rv lead was then surgically abandoned and this crt-d was replaced.The noise was suspected to be due to electromagnetic interference.An x-ray was performed, but no damage could clearly be seen.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 defibrillation, 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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