BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY II DR

    MDR report key: 1863098 · Received October 9, 2010

    Report

    Report Number
    2647346-2010-00613
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S43
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET HAPPENS AT EVERY FOLLOW UP APPOINTMENT. DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGACY II DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 828 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other IMK49JB45 IMPLANTABLE PACING LEAD| IMK49B52 IMPLANTABLE PACING LEAD