Model Number 4674 |
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 11/10/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that the left ventricular (lv) lead was not implanted successfully due to physician had trouble advancing the wire in the lead.This lead was suspected to have damage proximal to fourth electrode.Further, lead was flushed multiple times.This lead was never in service.No adverse patient effects were reported.
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Event Description
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It was reported that the left ventricular (lv) lead was not implanted successfully due to physician had trouble advancing the wire in the lead.This lead was suspected to have damage proximal to fourth electrode.Further, lead was flushed multiple times.This lead was never in service.No 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.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/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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