BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR/SOLETRA

    MDR report key: 1820865 · Received August 27, 2010

    Report

    Report Number
    MW5017257
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BROKEN LEAD WIRE "CRACKED" BATTERIES "DEAD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATOR/SOLETRA DEEP BRAIN STIMULATOR/GENERATOR MHY MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention