BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 980808 · Received January 16, 2008

    Report

    Report Number
    2182207-2008-00280
    Event Type
    Injury
    Date Received
    January 16, 2008
    Report Date
    October 17, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GREEN, ET AL. "DEEP BRAIN SIMULATION FOR NEUROPATHIC CEPHALALGIA." CEPHALALGIA, 2006, 26:561-567. THE ARTICLE DESCRIBES A PROSPECTIVE STUDY OF SEVEN PATIENTS WITH A VARIETY OF CEPHALALGIA IN WHOM DBS WAS USED. ALL PATIENTS HAD BEEN TREATED WITH A VARIETY OF MEDICATIONS WITHOUT SUCCESS. REPORTABLE EVENT: ONE PATIENT BEING TREATED FOR SEVERE BURNING AND STABBING PAIN AFFECTING THE RIGHT FOREHEAD, POST FRONTAL MENINGIOMA RESECTION, EXPERIENCED A CHRONIC IMPLANT INFECTION TREATED WITH ORAL ANTIBIOTICS. RECRUDESCENCE OF THE INFECTION AT 2 YEARS POST IMPLANT REQUIRED DEVICE REMOVAL AND SUCCESSFULL REIMPLANT AT A LATER DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R LEAD MODEL 3387 (N=2)| IPG (N=1)| LEAD EXTENSIONS (N=2)