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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC PERIMOUNT VALVE; REPLACEMENT HEART-VALVE

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EDWARDS LIFESCIENCES LLC PERIMOUNT VALVE; REPLACEMENT HEART-VALVE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Heart Block (4444)
Event Type  Injury  
Event Description
Medtronic received information that during the implant of an edwards perimount valve, complete heart block (chb) was reported and a permanent pacemaker was implanted five days later.No further adverse patient effects were reported.(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
PERIMOUNT VALVE
Type of Device
REPLACEMENT HEART-VALVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
MDR Report Key17533324
MDR Text Key321044194
Report NumberMW5140228
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 04/24/2017
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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