Model Number 0673 |
Device Problems
Connection Problem (2900); Device Dislodged or Dislocated (2923); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2023 |
Event Type
Injury
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Event Description
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It was reported that the impedance associated with the right ventricular lead was abnormal and the lead was discovered to be detached from the implantable cardioverter defibrillator (icd).The lead was successfully replaced, and no additional adverse patient effects were reported.The lead is expected to be returned for analysis.
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Event Description
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It was reported that the impedance associated with the right ventricular lead was abnormal and the lead was discovered to be detached from the implantable cardioverter defibrillator (icd).The lead was successfully replaced, and no additional adverse patient effects were reported.The lead was returned 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/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.A stylet insertion test was also performed and indicated no blockage in the lead lumen.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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