BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE LEAD

    MDR report key: 683582 · Received November 7, 2003

    Report

    Report Number
    2124215-2003-06134
    Event Type
    Malfunction
    Date Received
    November 7, 2003
    Date of Event
    September 12, 2003
    Report Date
    September 12, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 INTERVENE LEAD IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 497-23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other