BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY II DR

    MDR report key: 711712 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13513
    Event Type
    Injury
    Date Received
    May 9, 2006
    Date of Event
    February 3, 2006
    Report Date
    February 3, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    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

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT DURING THE FOLLOW-UP VISIT, THIS PACEMAKER WAS PACING AT THE MAXIMUM SENSOR RATE (MSR) OF 120PPM. A MAGENT WAS PLACED OVER THE DEVICE, WHICH EXHIBITED A RATE OF 100PPM; HOWEVER, WHEN THE MAGNET WAS REMOVED THE DEVICE BEGAN TO PACE AT THE MSR. IT WAS NOTED THAT THE PATIENT SUFFERED A STROKE IN SEPTEMBER 2005, AND THE PHYSICIAN SUSPECTS THE DEVICE HAS BEEN PACING AT THE MSR SINCE THAT TIME. THIS DEVICE IS INCLUDED IN THE HERMETIC SEALING COMPONENT ADVISORY POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II DR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1286 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention