BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1251665 · Received December 1, 2008

    Report

    Report Number
    6000002-2008-09370
    Event Type
    Death
    Date Received
    December 1, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 10, 2008
    Manufacturer
    EDWARDS LIFESCINECES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED APPROXIMATELY AFTER AN IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. PATIENT HAD TWO OTHER DEVICES IMPLANTED. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL# 6900P, WAS IMPLANTED. REFER TO MFR REPORT# 60000002-2008-09368. IT WAS ADDITIONALLY REPORTED THAT A THIRD DEVICE, MODEL# 6900P, WAS IMPLANTED. REFER TO MFR REPORT# 6000002-2008-09369.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCINECES 4900 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death