Model Number 4592 |
Device Problems
Difficult to Insert (1316); Device Sensing Problem (2917); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2022 |
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 unfavorable numbers in sensing and thresholds.It was noted that this was caused by poor placement.During a generation change, the physician explanted and replaced the lead successfully.There were no adverse patient effects reported.The lead will be 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.Measurements 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 explanted due to unfavorable numbers in sensing and thresholds.It was noted that this was caused by poor placement.During a generation change, the physician explanted and replaced the lead successfully.There were no adverse patient effects reported.The lead will be returned for analysis.
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Search Alerts/Recalls
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