BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA 60 DDDR IS-1

    MDR report key: 1253838 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40575
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 ALTRUA 60 DDDR IS-1 IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC S603 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention THE DEVICE 4136/283283 WAS IMPLANTED 11-JUL-2008| THE DEVICE 4135/283398 WAS IMPLANTED 11-JUL-2008