Model Number 4674 |
Device Problems
Positioning Problem (3009); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
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Event Description
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It was reported that this left ventricular (lv) lead was not successfully implanted due to unknown product performance issue.This lead was never in service.No adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.This supplemental report was created to capture additional information.Additional information indicated that the lead was not successfully implanted due to placement difficulty, too narrow of a branch.This does not meet reportable criteria.
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Event Description
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It was reported that this left ventricular (lv) lead was not successfully implanted due to unknown product performance issue.This lead was never in service.No adverse patient effects were reported.Additional information received indicated that the lead was attempted due to placement difficulty caused by the anatomy of the patient.No adverse patient effects were reported.
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Search Alerts/Recalls
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