BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 513395 · Received February 18, 2004

    Report

    Report Number
    513395
    Event Type
    Injury
    Date Received
    February 18, 2004
    Date of Event
    January 6, 2004
    Report Date
    January 16, 2004
    Manufacturer
    MEDTRONIC HEART VALVE, CUSTOMER QUALITY AFFAIRS
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSPITAL FOR MITRAL VALVE ANNULOPLASTY AND VALVULOPLASTY SECONDARY TO MITRAL VALVE PROLAPSE AND REGURGITATION. IN 2004 PT HAD A MEDTRONIC FUTURE BAND 638B PLACED. TRANSESOPHAGEAL CARDIOGRAPHY SHOWED NO MITRAL VALVE REGURGITATION AT END OF SURGERY. TWELVE HOURS POST OP, PT HAD TO BE RETURNED TO SURGERY FOR MITRAL VALVE REPLACEMENT SECONDARY TO SEVERE MITRAL VALVE REGURGITATION AND CARDIOGENIC SHOCK. MEDTRONIC FUTURE BAND WAS REMOVED AT THAT TIME. ETIOLOGY OF POST OP SEVERE MITRAL VALVE REGURGITATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC FUTURE BAND 638B KRH MEDTRONIC HEART VALVE, CUSTOMER QUALITY AFFAIRS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention