BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY DR

    MDR report key: 1041984 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34667
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY DR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1275 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention THE DEVICE 487-/08170B WAS IMPLANTED 15-SEP-1984| THE DEVICE 1291/149022 WAS IMPLANTED 19-MAR-2008| THE DEVICE 479-/05818B WAS IMPLANTED 15-SEP-1984| THE DEVICE 4137/282750 WAS IMPLANTED 19-MAR-2008