BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1057810 · Received June 6, 2008

    Report

    Report Number
    2182207-2008-03036
    Event Type
    Injury
    Date Received
    June 6, 2008
    Report Date
    May 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: PLAHA P, KAHN S, GILL SS. BILATERAL STIMULATION OF THE CAUDAL ZONA INCERTA NUCLEUS FOR TREMOR CONTROL. J NEUROL NEUROSURG PSYCHIATRY 2008; 79(5): 504-513. THE VENTROLATERAL (VL) NUCLEUS OF THE THALAMUS IS THE COMMONLY CHOSEN TARGET FOR DEEP BRAIN STIMULATION (DBS) TO ALLEVIATE TREMOR. HOWEVER, IT HAS A POOR EFFICACY IN ALLEVIATING PROXIMAL TREMOR AND PATIENTS MAY DEVELOP TOLERANCE TO THE ACTION COMPONENT OF TREMOR. WE PERFORMED BILATERAL STIMULATION OF THE CAUDAL OR MOTOR PART OF THE ZONA INCERTA NUCLEUS (CZI) TO DETERMINE ITS SAFETY AND EFFICACY IN ALLEVIATING TREMOR. FIVE PT'S WITH PARKINSONIAN TREMOR AND 13 WITH A RANGE OF TREMORS (HOLMES (HT), CEREBELLAR (CT), ESSENTIAL (ET), MULTIPLE SCLEROSIS (MS) AND DYSTONIC TREMOR (DT)) AFFECTING BOTH THE PROXIMAL AND DISTAL BODY PARTS UNDERWENT MRI GUIDED, BILATERAL CZI DBS. TREMOR WAS ASSESSED AT BASELINE AND AT A MEAN FOLLOW-UP OF 12 MONTHS. IN CONTRAST TO BILATERAL DBS OF THE VL NUCLEUS, IT IMPROVES ALL COMPONENTS OF TREMOR AFFECTING BOTH THE DISTAL AND PROXIMAL LIMBS AS WELL AS THE AXIAL MUSCULATURE. REPORTABLE EVENT: TWO PTS DEVELOPED TRANSIENT STIMULATION-RELATED DISEQUILIBRIUM, WITH ONE LASTING FOR 8 WEEKS AND THE OTHER FOR 8-10 WEEKS POST-SURGERY. IN BOTH CASES, OEDEMA WAS SEEN IN THE TARGET REGION, EXTENDING INTO THE PRELEMNISCAL RADIATION ON THE INTRAOPERATIVE MRI SCAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LEAD MODEL 3389 N=1| PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2| KINETRA MODEL 7428 N=1