Model Number 4671 |
Device Problems
High impedance (1291); Positioning Problem (3009); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that this left ventricular (lv) lead was an attempted implant due to high impedance measurements and high capture thresholds.The physician opted to replace the lead and a new one was successfully implanted.No adverse patient effects were reported.This lead has been received for analysis.
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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 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 left ventricular (lv) lead was an attempted implant due to high impedance measurements and high capture thresholds.The physician opted to replace the lead and a new one was successfully implanted.No adverse patient effects were reported.This lead has been received for analysis.
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Search Alerts/Recalls
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