BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY DR

    MDR report key: 1041478 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32062
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    December 30, 2007
    Report Date
    March 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    Z1032-39/5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY DR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1274 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other THE DEVICE 1290/791965 WAS IMPLANTED 20-MAR-2008| THE DEVICE 4035/205052 WAS IMPLANTED 08-JAN-1999| THE DEVICE 4271/225313 WAS IMPLANTED 08-JAN-1999