BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA BATTERY/GENERATOR

    MDR report key: 1020018 · Received March 27, 2008

    Report

    Report Number
    MW5006046
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    November 4, 2005
    Report Date
    March 27, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS THAT SHE WAS IMPLANTED WITH THE NEUNO STIMULATOR IN 2005. AT THAT TIME THE MEDTRONIC REP SET THE DEVICE AT 6 VOLTS 24/7 FOR ONE AND A HALF YEARS. THIS CAUSED THE PT TO HAVE DECREASED SPEECH AND EYE APRAXIA. PATIENT REC'D A CT SCAN AND WAS TOLD THAT THE LEADS WERE VERY DEEP, AND THAT THE BATTERIES WERE DEPLETED DUE TO THE HIGH VOLTAGE. PATIENT WENT FOR A SECOND OPINION, PT HAD AN MRI AND WAS TOLD THAT THE DEVICE WAS NOT PROGRAMMED. PT HAD SURGERY TO REPLACE BATTERY AND WAS INFORMED THAT REPS ARE NOT SUPPOSED TO PROGRAM THE DEVICES. PATIENT STATES THAT IN 2007 DUE TO "EYE ARAXINA" SHE FELL DOWN HER STAIRS AND FRACTURED HER RIGHT ARM AND ELBOW AND HAD TO HAVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA BATTERY/GENERATOR NONE MHY MEDTRONIC 7428 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R