BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1662279 · Received April 16, 2010

    Report

    Report Number
    3007566237-2010-03119
    Event Type
    Injury
    Date Received
    April 16, 2010
    Report Date
    March 16, 2010
    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

    (B) (4).

    Description of Event or Problem · 1

    LITERATURE: RESNICK AS, FOOTE KD, RODRIGUEZ RL, ET AL. THE NUMBER AND NATURE OF EMERGENCY DEPARTMENT ENCOUNTERS IN PATIENTS WITH DEEP BRAIN STIMULATORS. J NEUROL. JAN;257(1):122-131. SUMMARY: THE OBJECTIVE OF THE STUDY WAS TO REVIEW THE NUMBER AND THE NATURE OF ED ENCOUNTERS IN PATIENTS WITH DBS DEVICES IMPLANTED FOR MOVEMENT AND NEUROPSYCHIATRIC DISORDERS. THE ENCOUNTERS REVIEWED INCLUDED 215 PTS IMPLANTED AT (B) (4), AS WELL AS THOSE IMPLANTED AT OUTSIDE INSTITUTIONS, AS LONG AS THEY WERE FOLLOWED AT UF. EVENT: ONE ET PT EXPERIENCED INFECTION/HARDWARE REMOVAL WHICH DID NOT RESULT IN AN ER VISIT. NO FURTHER INFO WAS PROVIDED. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2010-03105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention