BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1946756 · Received December 27, 2010

    Report

    Report Number
    3007566237-2010-10775
    Event Type
    Injury
    Date Received
    December 27, 2010
    Date of Event
    October 15, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENT REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: BOUR LJ, CONTARINO MF. FONCKE EM, ET AL. LONG-TERM EXPERIENCE WITH INTRAOPERATIVE MICRORECORDING DURING DBS NEUROSURGERY IN STN AND GPI. ACTA NEUROCHIR (WIEN). DEC 2010;152(12):2069-2077. SUMMARY: INTRAOPERATIVE MICROELECTRODE RECORDING (MER) FOR TARGETING DURING DEEP BRAIN STIMULATION (DBS) PROCEDURES WAS EVALUATED BY THE AUTHORS OVER A PERIOD OF 4 YEARS, IN 57 CONSECUTIVE PTS WITH PARKINSON'S DISEASE, WHO RECEIVED DBS IN THE SUBTHALAMIC NUCLEUS (STN-DBS), AND 28 CONSECUTIVE PTS WITH EITHER DYSTONIA (23) OR PARKINSON'S DISEASE (FIVE), IN WHOM THE INTERNAL SEGMENT OF THE GLOBUS PALLIDUS (GPI-DBS) WAS TARGETED. THE RESULTS INDICATE THAT MER FACILITATES THE SELECTION OF THE FINAL ELECTRODE LOCATION IN STN-DBS AND GPI-DBS, AND BASED ON THE OBSERVED MER ACTIVITY, A PRE-SELECTION COULD BE MADE AS TO WHICH CHANNEL WOULD BE THE BEST CANDIDATE FOR MICRO-TEST STIMULATION AND AT WHICH DEPTH SHOULD BE STIMULATED. THE CHOICE OF THE FINAL LOCATION IS BASED ON INTRAOPERATIVE TEST STIMULATION, AND IT IS DEMONSTRATED THAT REGULARLY IT IS NOT THE CENTRAL CHANNEL THAT IS CHOSEN FOR IMPLANTATION. ON AVERAGE, THE TARGET AS DEFINED BY MER ACTIVITY INTENSITY WAS IN ACCORDANCE WITH THE MRI-BASED TARGETS BOTH FOR THE STN AND GPI. HOWEVER, THE POSITION OF THE BEST MER ACTIVITY DID NOT NECESSARILY CORRELATE WITH THE LOCUS THAT PRODUCED THE MOST BENEFICIAL CLINICAL RESPONSE ON MACROELECTRODE TESTING INTRAOPERATIVELY. REPORTABLE EVENT: ONE PT UNDERGOING STN-DBS POSTOPERATIVELY HAD A LEFTSIDED HEMIPARESIS DUE TO A RIGHT-SIDED SUBCORTICAL HEMATOMA. THE HEMIPARESIS COMPLETELY RESOLVED IN THE YEAR FOLLOWING SURGERY.

    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 Other UNKNOWN: MODEL, UNKNOWN LOT #, UNK| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT # UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389, LOT # UNK