BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 976557 · Received January 8, 2008

    Report

    Report Number
    2182207-2008-00069
    Event Type
    Injury
    Date Received
    January 8, 2008
    Report Date
    October 30, 2007
    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 "SIXTY HERTZ PALLIDAL DEEP BRAIN STIMULATION FOR PRIMARY TORSION DYSTONIA." NEUROLOGY, 2007, 69, 7, P681-688. THE ARTICLE DESCRIBES THE RESULTS FROM A RETROSPECTIVE STUDY THAT INVOLVED A SERIES OF 15 PTS BEING TREATED WITH BILATERAL OR UNILATERAL DEEP DRAIN STIMULATION (DBS) FOR MANAGEMENT OF SYMPTOMS RELATED MEDICALLY REFRACTORY DYSTONIA. REPORTABLE EVENT: TWO PTS EXPERIENCED HARDWARE RELATED WOUND INFECTIONS. BOTH DEVICES (IPG N=2) WERE REMOVED AND NEW DEVICES IMPLANTED FOLLOWING TREATMENT WITH IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R LEAD MODEL 3387| LEAD EXTENSION MODEL 7482