BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND II

    MDR report key: 1854817 · Received October 5, 2010

    Report

    Report Number
    2647346-2010-00544
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    October 6, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P850051/S32
    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 DURING INTERROGATION THE DEVICE SHOWED NO PACING AND AN ELECTIVE REPLACEMENT INDICATOR TRIPPED ON (B)(6) 2009. IT WAS ALSO REPORTED THAT THE COMPLAINANT COULD "FEEL A VIBRATION OVER THE PACER WHEN HE PLACES HIS HAND OVER THE DEVICE". CALLER INQUIRED IF THE DEVICE GIVES A PERCENTAGE PACING. THE 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 LEGEND II IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 8427 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other 6917-35 IMPLANTABLE PACING LEAD