BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 1313879 · Received February 16, 2009

    Report

    Report Number
    2182207-2009-01055
    Event Type
    Death
    Date Received
    February 16, 2009
    Date of Event
    November 25, 2008
    Report Date
    January 14, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: BHATIA S, OH M, WHITING T, QUIGLEY M, WHITING D. SURGICAL COMPLICATIONS OF DEEP BRAIN STIMULATION: A LONGITUDINAL SINGLE SURGEON, SINGLE INSTITUTION STUDY. STEREOTACT FUNCT NEUROSURG. 2008; 86(6): 367-372. LITERATURE SUMMARY: THIS REPORT ANALYZED THE COMPLICATIONS OF A SINGLE SURGEON AT ONE INSTITUTION OVER A 10-YEAR PERIOD. A TOTAL OF 191 PATIENTS RECEIVED 330 ELECTRODES IMPLANTS. THERE WERE 59 COMPLICATIONS IN 53 OF THE 191 PATIENTS. 'PATIENT DIED DUE TO A GANGRENOUS LIMB AND ITS SEQUELAE AFTER BEING TAKEN OFF COUMADIN FOR THE DBS IMPLANTATION.' SEE MANUFACTURER REPORT NUMBER: 2182207200901002.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD| EXTENSION: MODEL EXTENSION MVD| EXPLANTED: