BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1052630 · Received May 27, 2008

    Report

    Report Number
    2182207-2008-02819
    Event Type
    Injury
    Date Received
    May 27, 2008
    Report Date
    April 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: YOKOCHI F, BURBAUD P. NEUROSURGERY FOR NEUROACANTHOCYTOSIS. IN: WALKER RH, SAIKI S, DANEK A, EDS. NEUROACANTHOCYTOSIS SYNDROMES II. ANOTHER COUNTRY: SPRINGER-VERLAG; 2008:255-269. NEUROACANTHOCYTOSIS (NA) IS A GROUP OF NEURODEGENERATIVE DISEASES CHARACTERIZED BY THE PRESENCE OF ACANTHOCYTES IN PERIPHERAL BLOOD AND VARIOUS TYPES OF INVOLUNTARY MOVEMENTS WHICH ARE OFTEN RESISTANT TO MEDICAL TREATMENT. WE REPORT DATA CONCERNING FOUR NA PATIENTS WHO BENEFITED FROM FUNCTIONAL SURGERY: TWO HAD PALLIDOTOMIES AND TWO HAD DEEP BRAIN STIMULATION (DBS) OF THE INTERNAL PALLIDUM (GPI). IN THE PATIENTS WHO UNDERWENT DBS. GPI 40HZ STIMULATION GAVE THE BEST CLINICAL BENEFIT, IMPROVING CHOREA WITHOUT AN EFFECT UPON HYPOTONIA. HIGHER FREQUENCY STIMULATION (130HZ) WAS EFFECTIVE FOR DYSTONIA BUT INCREASED CHOREA, WORSENED DYSARTHRIA AND INDUCED DROOLING. REPORTABLE EVENT: PT 3 WAS A MAN WITH AN 8-YEAR HISTORY OF A CHOREATIC-DYSTONIC SYNDROME, DYSARTHRIA AND GENERALIZED EPILEPTIC SEIZURES WHO PRESENTED WITH RECURRENT DISTRESSING TASTELESS BELCHING. TWO MONTHS AFTER DBS, A PARTIAL RELAPSE OCCURRED, AND BELCHING AND BREATHING DYSKINESIA REAPPEARED, ALTHOUGH TONGUE-BITING DID NOT. CHANGES IN STIMULATION SETTINGS WERE INEFFECTIVE. MRI REVEALED THAT THE RT ELECTRODE NEEDED TO BE REPOSITIONED. THE FIRST RT ELECTRODE WAS LEFT IN PLACE AND A SECOND ELECTRODE WAS INTRODUCED MORE MEDIALLY ON THE SAME SIDE, 3 MONTHS AFTER THIS SECOND INTERVENTION, CHOREA, BELCHING AND DYSARTHRIA WERE IMPROVED BY GPI 40HZ STIMULATION. THE DYSTONIA SUB-SCORE WAS SLIGHTLY IMPROVED BY 120HZ GPI STIMULATION BUT AT THIS FREQUENCY, CHOREA AND DYSARTHRIA WERE WORSENED WITH DROOLING. THERE WAS NO EFFECT ON GAIT WHATEVER THE SETTINGS USED. GPI STIMULATION AT 10 HZ WAS INEFFECTIVE.

    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 32 YR Required Intervention LEAD: MODEL 3387 N=1| KINETRA: MODEL 7428 N=1| EXTENSION: MODEL UNK N = 2| PROGRAMMER: MODEL UNK N = 1