BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE II

    MDR report key: 1861692 · Received October 8, 2010

    Report

    Report Number
    2647346-2010-00588
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S16
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE PACEMAKER HAD NO RESPONSE TO THE MAGNET AND NO GREEN LIGHTS WOULD APPEAR WHEN THE PROGRAMMING HEAD WAS PLACED OVER IT. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE II IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 7086 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD