Model Number 4674 |
Device Problems
Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2022 |
Event Type
Injury
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Event Description
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It was reported that this left ventricular (lv) lead was exhibiting high capture thresholds.An x-ray imaged noticed that the lead had pulled back from original implant position.This lead was successfully explanted and replaced.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 exhibiting high capture thresholds.An x-ray imaged noticed that the lead had pulled back from original implant position.This lead was successfully explanted and replaced.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, visual inspection of the lead was performed.Inspection of the lead body and electrode tip found no anomalies.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.
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Search Alerts/Recalls
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