BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1014495 · Received March 17, 2008

    Report

    Report Number
    2182207-2008-01319
    Event Type
    Injury
    Date Received
    March 17, 2008
    Report Date
    March 26, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: EGIDI ET AL. A SURVEY OF ITALIAN CASES OF DYSTONIA TREATED BY DEEP BRAIN STIMULATION. J OF NEUROLOGICAL SCIENCES 2007;51(4):153-8. THE ARTICLE DESCRIBES A RETROSPECTIVE SURVEY WITH THE AIM OF PRESENTING THE COMPLETE SERIES OF DYSTONIC PATIENTS TREATED WITH BILATERAL DBS IN ORDER TO DESCRIBE LOCAL CURRENT PRACTICES. A TOTAL OF 7 CENTERS PARTICIPATED IN THE SURVEY AND OPERATED ON 69 PATIENTS. SURGICAL COMPLICATIONS OCCURRED IN 13 OF THE 69 PATIENTS (19%). ONE PATIENT EXPERIENCED A FOCAL WHITE EDEMA. TREATMENT AND OUTCOME INFORMATION WAS NOT PROVIDED.

    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 UNK Other LEAD UNK (N=1)| IPG UNK (N=1 OR 2)| LEAD EXTENSION UNK (N=2)