Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) and right ventricular (rv) lead exhibited noise, oversensing and high out of range pacing impedance measurements greater than 2,000 ohms.A device header seal plug problem was suspected.An invasive procedure was performed.The device was explanted and replaced and the lead was surgically abandoned and replaced.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 tool marks on the case and bloody fluid contamination in the lead barrels.Further inspection noted that there was a hole in the left ventricular (lv) and right ventricular (rv) seal plugs.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.Impedance testing was completed and all measurements were within normal limits.A series of electrical tests was also performed, and again, normal device function was observed.Laboratory analysis confirmed damage to the seal plugs, however, did not confirm the noise or high out of range pacing impedance measurements as this was not duplicated during laboratory testing.
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