Model Number U228 |
Device Problem
Pocket Stimulation (1463)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 08/30/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) experienced phrenic nerve stimulation.This device was explanted, and a new device was placed.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
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Event Description
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It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) experienced phrenic nerve stimulation.This device was explanted, and a new device was placed.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.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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Search Alerts/Recalls
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