BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1053631 · Received May 23, 2008

    Report

    Report Number
    2182207-2008-02761
    Event Type
    Injury
    Date Received
    May 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ZESIEWICZ TA, SULLIVAN KL, HOFFMAN M, ET AL. DELAYED THALAMIC INTRACRANIAL HEMORRHAGE IN ESSENTIAL TREMOR PT FOLLOWING DEEP BRAIN STIMULATION. EUR NEUROL 2008;59(3-4):187-189. WE REPORT THE CASE OF A MAN WITH ET AND A HISTORY OF CONTROLLED HYPERTENSION WHO DEVELOPED A DELAYED THALAMIC INTRACEREBRAL HEMORRHAGE (ICH) ALMOST 9 WEEKS FOLLOWING DBS SURGERY. REPORTABLE EVENT: THE DAY AFTER HIS NINE WEEK EVAL, WHICH WAS NORMAL, THE PT WOKE UP FROM AN AFTERNOON NAP WITH RIGHT-SIDED ARM AND LEG WEAKNESS, SLURRED SPEECH, AND A RIGHT FACIAL DROOP. NEUROLOGICALLY, THE PT WAS LETHARGIC, ORIENTED TO HIS NAME AND DISORIENTED TO PLACE AND TIME. CRANIAL NERVE EXAMINATION WAS SIGNIFICANT FOR A RIGHT FACIAL PARESIS. MOTOR EXAMINATION DEMONSTRATED RIGHT UPPER AND LOWER EXTREMITY WEAKNESS. SENSORY EXAMINATION DEMONSTRATED RIGHT HEMI-HYPOESTHESIA, AND THE PT HAD AN EXTENSOR PLANTAR REFLEX ON THE RIGHT. CT AND MRI OF THE BRAIN WITHOUT CONTRAST SHOWED A LEFT-SIDED THALAMIC ICH ADJOINING THE DISTAL PORTION OF THE DEEP BRAIN STIMULATOR ELECTRODE. HIS DSB UNIT WAS TURNED OFF. HIS BLOOD PRESSURES REMAINED STABLE, AND HE IMPROVED CLINICALLY HAVING NORMAL MMSE, MILD DYSARTHRIA, MILD RIGHT FACIAL WEAKNESS, AND RIGHT UPPER AND LOWER EXTREMITY WEAKNESS IN THE ENSUING 6 WEEKS. HE WAS ABLE TO AMBULATE WITH THE USE OF A WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R EXTENSION MODEL UNK N=1| IPG SOLETRA MODEL 7426 N=1| PROGRAMMER MODEL UNK N=1