Model Number U128 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
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Patient Problem
Asystole (4442)
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Event Date 10/28/2023 |
Event Type
Injury
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Event Description
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It was reported that this implantable pacemaker exhibited noise, oversensing and pacing inhibition on the right ventricular channel.Additionally, the pacing impedance measurements are also trending down on the right ventricular channel.A lead fracture is suspected; however, it has not been confirmed.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was added to the following fields: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe event or problem field d6b: explant date h1: type of reportable event h6: impact codes.
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Event Description
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It was reported that this implantable pacemaker exhibited noise, oversensing and pacing inhibition on the right ventricular channel.Additionally, the pacing impedance measurements are also trending down on the right ventricular channel.A lead fracture is suspected; however, it has not been confirmed.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted and replaced.This device is expected to be returned for analysis.
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Manufacturer Narrative
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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 implantable pacemaker exhibited noise, oversensing and pacing inhibition on the right ventricular channel.Additionally, the pacing impedance measurements are also trending down on the right ventricular channel.A lead fracture is suspected; however, it has not been confirmed.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted and replaced.This device is expected to be returned for analysis.
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Search Alerts/Recalls
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