Model Number 4677 |
Device Problems
Defective Device (2588); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that when this left ventricular (lv) lead was set to be implanted, the guidewire pierced the lead body, subsequently, the lead suffered insulation damage.It was successfully replaced with a new one.No additional adverse patient effects were reported.
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Event Description
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It was reported that when this left ventricular (lv) lead was set to be implanted, the guidewire pierced the lead body, subsequently, the lead suffered insulation damage.It was successfully replaced with a new one.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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Search Alerts/Recalls
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