Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual and mechanical inspection of the rv set screw was performed and no anomalies were noted.The lead barrel was found to be free of obstruction.There was a hole noted in the rv seal plug.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.Laboratory analysis was unable to reproduce the clinical observations during testing.
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Boston scientific received information that the patient with this cardiac resynchronization therapy pacemaker (crt-p) was seen for a recent patient follow up and reported that he experienced a fall in (b)(6) 2017.A review of the memory revealed that an episode was recorded where there was oversensing of the respiratory rate trend (rrt) signal.The patient had a slow intrinsic rhythm and pacing inhibition did not last longer than two seconds.The pacing impedance measurements have remained stable, but there was an increase to 800 ohms around the day of the patient's fall.Further testing was performed and both noise was able to be recreated with patient movements as well pacing impedance measurements were above 3,000 ohms.A chest x-ray was performed and no issues were observed with the non-boston scientific right ventricular (rv) lead or with the connection.Boston scientific technical services (ts) was contacted and discussed additional troubleshooting.A revision was performed.The physician performed a tug test on the rv lead and confirmed that it was secured in the header.The terminal pin rv lead was then removed from the port and measurements were taken on the psa; all measurements were in normal range and no noise was observed.The rv lead was reconnected to the crt-p; however, noise was able to be recreated with lead manipulation.The crt-p was explanted and successfully replaced.When the rv lead was connected to the new device, the noise was still present.As a result, the non-boston scientific rv lead was capped and successfully replaced.No additional adverse patient effects were reported.
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