Model Number 0672 |
Device Problems
Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2024 |
Event Type
Injury
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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 an alert had been generated for right ventricular automatic threshold (rvat) detected as greater than programmed amplitude or suspended.Capture could not be confirmed on the presenting electrogram, and stored data identified potential rv loss of capture.Dislodgement of this rv lead is suspected.The physician has not determined a course of action at this time and the lead remains in service.No adverse patient effects were reported.
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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 an alert had been generated for right ventricular automatic threshold (rvat) detected as greater than programmed amplitude or suspended.Capture could not be confirmed on the presenting electrogram, and stored data identified potential rv loss of capture.Dislodgement of this rv lead is suspected.The physician has not determined a course of action at this time and the lead remains in service.No adverse patient effects were reported.It was reported that defibrillation therapy was programmed off and a lead revision procedure will be scheduled in the near future.No adverse patient effects were reported.
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Manufacturer Narrative
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This product is not being returned for evaluation.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 an alert had been generated for right ventricular automatic threshold (rvat) detected as greater than programmed amplitude or suspended.Capture could not be confirmed on the presenting electrogram, and stored data identified potential rv loss of capture.Dislodgement of this rv lead is suspected.The physician has not determined a course of action at this time and the lead remains in service.No adverse patient effects were reported.It was reported that defibrillation therapy was programmed off and a lead revision procedure will be scheduled in the near future.No adverse patient effects were reported.It was reported that this rv lead was subsequently explanted.The replacement lead was positioned on the ventricular septum with satisfactory lead measurements.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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