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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS CARPENTIER REPLACEMENT HEART VALVE; REPLACEMENT HEART-VALVE

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EDWARDS CARPENTIER REPLACEMENT HEART VALVE; REPLACEMENT HEART-VALVE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Atrial Fibrillation (1729)
Event Type  Injury  
Event Description
Medtronic received information that two days following the implant of this transcatheter bioprosthetic valve, patient went into atrial fibrillation and an amiodarone drip was started.Twelve days after the amiodarone drip treatment a permanent pacemaker was implanted.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
REPLACEMENT HEART VALVE
Type of Device
REPLACEMENT HEART-VALVE
Manufacturer (Section D)
EDWARDS CARPENTIER
MDR Report Key17537637
MDR Text Key321133928
Report NumberMW5144489
Device Sequence Number1
Product Code DYE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 01/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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