BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U128 |
Device Problems
Signal Artifact/Noise (1036); Connection Problem (2900)
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Patient Problem
No Code Available (3191)
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Event Date 09/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has been returned for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited right ventricular (rv) noise both with and without patient isometrics.A revision procedure was performed to revise the rv lead.An attempt was made to remove the lead from the device; however, it was stuck, and the physician noted that the terminal pin was not fully past the setscrew in the header.The device was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Patient code 3191 is being used to capture the additional intervention performed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination 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 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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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited right ventricular (rv) noise both with and without patient isometrics.A revision procedure was performed to revise the rv lead.An attempt was made to remove the lead from the device; however, it was stuck and the physician noted that the terminal pin was not fully past the setscrew in the header.The device was explanted and replaced.No additional adverse patient effects were reported.
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