Model Number 4675 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2024 |
Event Type
Injury
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Event Description
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It was reported that this left ventricular (lv) lead exhibited dislodgement.This lead was explanted and replaced.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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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Inspection of the lead body and electrode tip found no anomalies.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.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 this left ventricular (lv) lead exhibited dislodgement.This lead was explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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