BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBS EXTENSION

    MDR report key: 3181815 · Received June 21, 2013

    Report

    Report Number
    3007566237-2013-02050
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE EVENT REGARDING THE PATIENT'S EXTENSION EROSION AND INFECTION WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3007566237-2012-02478. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED IN THIS MANUFACTURER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283573 DBS EXTENSION STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7482-51

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention