BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DASH

    MDR report key: 1042370 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34269
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS 292-03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 4269/206157 WAS IMPLANTED 20-DEC-1993