Model Number 0672 |
Device Problems
Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
Injury
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Event Description
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It was reported that this lead was explanted due to high capture thresholds and loss of capture (loc), due to a suspected micro-dislodgement.Even though fluoroscopy did not confirm the dislodgement, it still remains as the most probable cause.A new lead was implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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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Event Description
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It was reported that this lead was explanted due to high capture thresholds and loss of capture (loc), due to a suspected micro-dislodgement.Even though fluoroscopy did not confirm the dislodgement, it still remains as the most probable cause.A new lead was implanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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