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Model Number LSP201A |
Device Problems
Failure to Interrogate (1332); Stretched (1601); Capturing Problem (2891); Device Dislodged or Dislocated (2923)
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Patient Problem
Embolism/Embolus (4438)
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Event Date 11/11/2023 |
Event Type
Injury
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Event Description
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It was reported the patient underwent a leadless pacemaker (lp) implant.During implant, after fixation at a chosen location, the capture threshold increased but the lp remained implanted.The following day, the lp failed to be interrogated.A chest x-ray was completed to reveal the lp had dislodged and migrated to the opposite side of the heart.The lp was successfully retrieved, and it was noted to have a stretched helix.No replacement device was implanted.The patient was stable.
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Manufacturer Narrative
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Device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No anomaly was noted, the device passed all tests.The reported complaint of dislodgement and capturing problem were not confirmed.Visual inspection showed that the inner helix was clogged with blood/body tissue, and the outer helix was stretched out of specification.The helix elongation is consistent with having occurred during procedure.Telemetry, pacing and output features were analyzed, and the device exhibited normal electrical characteristics without any anomalies.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.
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Search Alerts/Recalls
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