BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 921649 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03025
    Event Type
    Other
    Date Received
    September 21, 2007
    Report Date
    September 30, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: OKUN, MD, ET AL. "MANAGEMENT OF REFERRED DEEP BRAIN STIMULATION FAILURES." ARCH NEUROLOGY, 2005; AUG: VOL. 62(8) P1250-1255. THE ARTICLE DESCRIBES THE EXPERIENCE OF 41 PATIENTS COMPLAINING OF SUBOPTIMAL RESULTS FROM DBS SURGERY. THE VARIOUS CAUSES FOR THE SUBOPTIMAL RESULTS WERE REPORTED. REPORTABLE EVENTS: THE DBS LEAD (N=8) - EIGHT PATIENTS EXPERIENCED MISPLACED LEADS THAT WERE REPOSITIONED (PATIENTS 1, 23, 24, 31, 36, 39, 40). THE DBS LEAD (N=3) - TWO PATIENTS EXPERIENCED PROGRAMMING DIFFICULTIES AND MISPLACED LEADS THAT WERE REPOSITIONED (PATIENTS 27, 28, 38). THE DBS LEAD (N=8) - EIGHT PATIENTS EXPERIENCED MISPLACED LEADS THAT WERE NOT REPOSITIONED (PATIENTS 3, 4, 12, 16, 20, 29, 33, 41). THE DBS LEAD (N=3) - THREE PATIENTS EXPERIENCED DEMENTIA AND MISPLACED LEADS THAT WERE NOT REPOSITIONED (PATIENTS 2, 8, 9). THE DBS LEAD (N=2) - TWO PATIENTS EXPERIENCED MISPLACED LEADS THAT WERE NOT REPOSITIONED ALONG WITH MISDIAGNOSIS (PATIENTS 13, 26).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR