It was reported that this patient has complete heart block, cardiomyopathy and is pacemaker dependent.The system has been exhibiting pacing impedance measurements less than 200 ohms on the right ventricular (rv) channel with elevated threshold measurements and no capture despite maximum device outputs.Additionally, shock impedance measurements have been in the lower range between 64 ohms and 89 ohms.The physician suspects lead insulation damage.A revision procedure was performed and this device and the associated rv lead were removed from service and replaced.No additional adverse patient effects were reported.
|
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.
|