BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 978863 · Received January 11, 2008

    Report

    Report Number
    2182207-2008-00205
    Event Type
    Injury
    Date Received
    January 11, 2008
    Report Date
    November 2, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: VIDAILHET ET AL. "BILATERAL, PALLIDAL, DEEP-BRAIN STIMULATION IN PRIMARY GENERALIZED DYSTONIA: A PROSPECTIVE 3 YEAR FOLLOW-UP STUDY" LANCET NEUROLOGY/2007/6/3/223-229. THE ARTICLE DESCRIBES THE RESULTS OF A PROSPECTIVE 3 YEAR FOLLOW-UP STUDY INVOLVING 22 PATIENTS BEING TREATED WITH BILATERAL PALLIDAL DEEP BRAIN STIMULATION (DBS) FOR SYMPTOMS RELATED TO PRIMARY GENERALIZED DYSTONIA. THE OBJECTIVE OF THE STUDY WAS TO ASSES THE LONG TERM EFFECT OF PALLIDAL STIMULATION. A NUMBER OF COMPLICATIONS WERE INCLUDED IN THE RESULTS. A FEMALE PATIENT (11) EXPERIENCED AN INFECTION IN THE PARIETAL REGION AT THE CONNECTION BETWEEN THE ELECTRODE AND EXTENSION LEAD. AFTER THE INITIAL TREATMENT WITH ANTIBIOTICS THE PATIENT EXPERIENCED A SCALP EROSION AND THE INFECTION SPREAD TO THE ELECTRODES AND THE ENTIRE SYSTEM WAS REMOVED AT 29 MONTHS POST IMPLANT (IPG, LEADS N=2 AND LEAD EXTENSIONS N=2).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R LEAD EXTENSIONS (N=2)| IPG (N=1)| DBS LEAD UNK (N=1)