BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1353057 · Received March 30, 2009

    Report

    Report Number
    2182207-2009-02234
    Event Type
    Injury
    Date Received
    March 30, 2009
    Date of Event
    August 4, 2008
    Report Date
    February 6, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: MARTIN AJ, LARSON PS, OSTREM JL, STARR PA. INTERVENTIONAL MAGNETIC RESONANCE GUIDANCE OF DEEP BRAIN STIMULATOR IMPLANTATION OF PARKINSON DISEASE. TOP MAGN RESON IMAGING. 2009;19(4):213-221. SUMMARY: REVIEW THE USE OF INTERVENTIONAL MAGNETIC RESONANCE IMAGE GUIDANCE FOR THE IMPLANTATION OF DEEP BRAIN STIMULATOR ELECTRODES. THE PATIENT DEVELOPED AN INFECTION ASSOCIATED WITH THE EXTENSION WIRE CONNECTING THE IPG TO THE DBS ELECTRODE. THIS REQUIRED COMPLETE REMOVAL OF THE ELECTRODES. THIS PATIENT WAS SUBSEQUENTLY RE-IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEADMVD: LOT# UNK| EXTENSION: MVD| IMPLANTED:| EXPLANTED:| PROGRAMMER| EXPLANTED:| IMPLANTED: