BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 981599 · Received January 17, 2008

    Report

    Report Number
    2182207-2008-00309
    Event Type
    Injury
    Date Received
    January 17, 2008
    Report Date
    January 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ALTERMAN ET AL. "DEEP BRAIN STIMULATION FOR TORSION DYSTONIA IN CHILDREN" CHILDS NERV SYST. 2007; 23(9): 1003-1040. THE ARTICLE DESCRIBES A STUDY INVOLVING 19 PATIENTS BEING TREATED WITH DEEP BRAIN STIMULATION (DBS) OF THE INTERNAL GLOBUS PALLIDUS (GPI) FOR SYMPTOMS RELATED TO DYSTONIA. A NUMBER OF COMPLICATIONS WERE REPORTED. FOUR PATIENTS DEVELOPED PERIOPERATIVE INFECTIONS RESULTING IN 5 DEVICES (UNSPECIFIED) BEING REMOVED. ALL PATIENTS WERE TREATED WITH ANTIBIOTICS AND HAD SUBSEQUENTLY RECEIVED NEW IMPLANTS AFTER THE INFECTIONS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R LEAD UNK (N=1)| LEAD EXTENSION (N=1)