Model Number 29VAVGJ-515 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Atrial Fibrillation (1729)
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Event Date 07/24/2022 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on (b)(6) 2022 a 29 mm masters valve was implanted.On (b)(6) 2022, paroxysmal atrial fibrillation was observed and treated with amiodarone and home medication (verapamil, metoprolol, potassium) was adjusted.The patient was reported to be in stable condition.
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Event Description
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Clinical study patient id: (b)(6).Subsequent to the previously filed report, additional information was received.The device was successfully implanted and is working as intended.
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Manufacturer Narrative
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An event of paroxysmal atrial fibrillation was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.
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Search Alerts/Recalls
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