Model Number 0672 |
Device Problems
Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2023 |
Event Type
Injury
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Event Description
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It was reported that this right ventricular (rv) lead was explanted due to unknown product performance issues.No additional information is available at the moment.No additional 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 explanted due to a dislodgement presented, which was conclusively determined through x-rays.No additional information is available at the moment.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Based on the instructions for use for this product, the dislodgement behavior is a known inherent risk of the use of this lead.A thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance.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 right ventricular (rv) lead was explanted due to a dislodgement presented, which was conclusively determined through x-rays.No additional information is available at the moment.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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