BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U125 |
Device Problems
Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Off-Label Use (1494); Device Sensing Problem (2917)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and right ventricular (rv) defibrillation lead, implanted in an off label manner, exhibited noise, oversensing and high out of range pacing impedance measurements greater than 2,000 ohms.Boston scientific technical services (ts) discussed troubleshooting options.An x-ray was taken and noted no anomalies.Monitoring will be continued.No adverse patient effects were reported.This product remains implanted and in service.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.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.Dimensional analysis of the header 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) and right ventricular (rv) defibrillation lead, implanted in an off label manner, exhibited noise, oversensing and high out of range pacing impedance measurements greater than 2,000 ohms.Boston scientific technical services (ts) discussed troubleshooting options.An x-ray was taken and noted no anomalies.Monitoring will be continued.No adverse patient effects were reported.This product remains implanted and in service.Additional information was received that the device was later explanted and replaced due to reported normal battery depletion.No adverse patient effects were reported.The product has been received for analysis.
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