Model Number 0673 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2023 |
Event Type
malfunction
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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 was not implanted successfully due to a bent or kinked.This lead was never in service, and a new lead was placed.No adverse patient effects were reported.
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Event Description
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It was reported that this right ventricular (rv) lead was not implanted successfully due to a bent or kinked.This lead was never in service, and a new lead was placed.No 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 and inner and outer insulation integrity.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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