BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD X2

    MDR report key: 1019434 · Received March 25, 2008

    Report

    Report Number
    2182207-2008-01454
    Event Type
    Injury
    Date Received
    March 25, 2008
    Report Date
    November 27, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    SAULEAU/CONTRAVERSIVE EYE DEVIATION DURING STIMULATION OF THE SUBTHALAMIC REGION. FEMALE, CONTRAVERSIVE EYE DEVIATION (CED) COULD BE DEMONSTRATED IF STIMULATORS WERE ACTIVATED SEPARATELY. FACE CONTRACTION INDICATES TONIC CONTRACTIONS OF THE CONTRALATERAL FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD X2 MHY MEDTRONIC NEUROMODULATION 3389 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention EXPLANTED| EXPLANTED| EXTENSION MODEL EXTENSION LOT#UNK| IMPLANTED| EXPLANTED| EXTENSION MODEL EXTENSION LOT#UNK| IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT#UNK| IMPLANTED| IMPLANTED| NEUROSTIMULATOR MODEL UNK SERIAL#UNK