Boston scientific received information that this implantable cardioverter defibrillator (icd) and the right atrial (ra) lead exhibited low, out-of-range (oor) pacing lead impedance measurement less than 200 ohms along with oversensing and pacing inhibition but without asystole.Subsequently, the lead was surgically abandoned while the device was explanted.No additional adverse patient effects were reported.The system was out of service.
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(b)(4).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.
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