BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3007566237-2012-02382

    MDR report key: 2771855 · Received October 4, 2012

    Report

    Report Number
    3007566237-2012-02382
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CEREBRAL HEMORRHAGE COMPLICATION OCCURRED DURING SURGERY ON A DEEP BRAIN STIMULATION PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention