BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1053612 · Received May 23, 2008

    Report

    Report Number
    2182207-2008-02769
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: NOVAK KE, NENONENE EK, BERNSTEIN LP, VERGENZ S, COZZENS JW, REZAK M. SUCCESSFUL BILATERAL SUBTHALAMIC NUCLEUS STIMULATION FOR SEGMENTAL DYSTONIA AFTER UNILATERAL PALLIDOTOMY. STEREOTACT FUNCT NEUROSURG 2008;86(2):80-86. A MALE PT WITH MEDICALLY INTRACTABLE, SEGMENTAL, EARLY-ONSET, PRIMARY TORSION DYSTONIA PRESENTED FOR SURGICAL CONSULTATION AFTER EXHAUSTING NEARLY ALL TREATMENT OPTIONS. MEDICATIONS, BOTULINUM TOXIN INJECTIONS, CERVICAL DENERVATION SURGERY, AND LEFTSIDED PALLIDOTOMY FAILED TO GIVE ADEQUATE RELIEF. THE PT WAS IMPLANTED WITH SUBTHALAMIC NUCLEUS STIMULATION (STN) LEADS BILATERALLY. AT 34 MOS AFTER INITIAL STN DBS SURGERY, THE PT INDICATED MODERATE IMPROVEMENT OF SYMPTOMS WITH SOME REMAINING PROBLEMS, AND THAT HE WAS "VERY SATISFIED" WITH THE RESULTS OF SURGERY. AT 16 MOS AFTER INITIAL SURGERY, ELECTRODE IMPEDANCE TESTING REVEALED THAT THE LEFT LEAD WAS FRACTURED. THE LEAD WAS ULTIMATELY REPLACED 19 MOS AFTER THE INITIAL SURGERY. UNFORTUNATELY, THE LEAD BECAME INFECTED 2 MOS AFTER REPLACEMENT, AND WAS REMOVED. THE EXTENSION WIRE AND IPG REMAINED IMPLANTED. THE PT WAS TREATED FOR THE INFECTION, AND A THIRD LEAD WAS IMPLANTED 3 MOS LATER USING MICROELECTRODE MAPPING, 2 YRS AFTER THE INITIAL SURGERY. REPORTABLE EVENT: FOLLOWING IMPLANTATION OF THIS THIRD LEAD, THE PT AGAIN DEVELOPED CELLULITIS AT THE SCALP INCISION THAT RESPONDED TO 6 WEEKS OF INTRAVENOUS VANCOMYCIN, AND MINOCYCLINE SUPPRESSIVE THERAPY.

    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 35 YR Other| R PROGRAMMER MODEL UNK N=1| NEURO STIMULATOR MODEL UNK N=2| EXTENSION MODEL UNK N=2| LEAD MODEL 3389 N=1