Model Number 18-5000 (JP) |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Nerve Damage (1979)
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Event Date 11/21/2023 |
Event Type
Injury
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Manufacturer Narrative
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No device deficiency reported.Phrenic nerve injury is a known potential adverse event for catheter ablation procedures disclosed in product labeling.
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Event Description
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During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, loss of phrenic nerve capture was observed while ablating the right superior pulmonary vein (rspv).Phrenic nerve capture could not be regained by the end of the procedure.No additional information has been provided for this reported event.
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Manufacturer Narrative
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No device deficiency reported.Phrenic nerve injury is a known potential adverse event for catheter ablation procedures disclosed in product labeling.
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Event Description
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During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, loss of phrenic nerve capture was observed while ablating the right superior pulmonary vein (rspv).Phrenic nerve capture could not be regained by the end of the procedure.No additional information has been provided for this reported event.
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Search Alerts/Recalls
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