Model Number 4518 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
Event Type
Injury
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Event Description
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It was reported that this left ventricular (lv) lead was explanted due to it was fractured.It was confirmed through a fluoroscopy.A new left ventricular (lv) lead was successfully implanted.No additional adverse patient effects were reported.
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Event Description
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It was reported that this left ventricular (lv) lead was explanted due to it was fractured.It was confirmed through a fluoroscopy.A new left ventricular (lv) lead was successfully 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.Measurements throughout this test were within normal limits.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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