Model Number 0672 |
Device Problems
Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2023 |
Event Type
Injury
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Event Description
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It was reported that this right ventricular (rv) lead had an anomaly with the helix compromising the lead and tissue interface.Furthermore, the rv lead was dislodged.This lead was surgically explanted, and a new lead was placed.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this right ventricular (rv) lead had an anomaly with the helix compromising the lead and tissue interface.Furthermore, this rv lead was dislodged.This lead was surgically explanted, and a new lead was placed.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
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Search Alerts/Recalls
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