BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 926829 · Received October 11, 2007

    Report

    Report Number
    2182207-2007-03195
    Event Type
    Other
    Date Received
    October 11, 2007
    Report Date
    May 10, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENTS ARE REPORTED BY COMPLICATION RATHER THAN THE PREFERRED PATIENT/DEVICE/COMPLICATION FORMAT DUE TO THE LIMITATIONS OF THE DATA. FOLLOW-UP IS IN PROCESS TO OBTAIN MORE PATIENT/EVENT SPECIFIC INFORMATION AND THE RESULTS WILL BE PROVIDED WHEN AVAILABLE. IT IS LIKELY THAT MANY PATIENTS EXPERIENCED MULTIPLE COMPLICATIONS DURING THE SAME EVENT WHICH WOULD SIGNIFICANTLY REDUCE THE NUMBER OF REPORTABLE EVENTS.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: MCCLELLAND III, MD ET AL. "MICROELECTRODE RECORDING-DETERMINED SUBTHALAMIC NUCLEUS LENGTH NOT PREDICTIVE OF STIMULATION-INDUCED SIDE EFFECTS." NEUROSURGICAL FOCUS. NOV 2005; VOL 19(5): E13. THE ARTICLE DESCRIBES A STUDY TO EVALUATE THE RELATIONSHIP BETWEEN THE MAPPING OF THE STN BY USING MER AND POSTOPERATIVE STIMULATION INDUCED SIDE EFFECTS. EIGHTY-TWO ELECTRODES WERE IMPLANTED IN 75 PATIENTS. A TOTAL OF 82 ELECTRODES WERE ASSOCIATED WITH 97 STIMULATION-INDUCED SIDE EFFECTS. BECAUSE A PARTICULAR ELECTRODE COULD YIELD MULTIPLE SIDE EFFECTS AND MULTIPLE ELECTRODES COULD BELONG TO THE SAME PATIENT, THE NUMBER OF SIDE EFFECTS COULD BE CORRELATED ONLY WITH THE NUMBER OF ELECTRODES AND NOT WITH THE NUMBER OF PATIENTS. REPORTABLE EVENTS: LEAD (N=49) PARESTHESIA, LEAD (N=13) DYSTONIC CONTRACTION, LEAD (N=8) EYELID-OPENING APRAXIA/OCULAR MOTOR EFFECTS, LEAD (N=6) DYSARTHRIA, LEAD (N=5) DYSKINESIA, LEAD (N=5) DIZZINESS/ATAXIA, LEAD (N=4) NUMBNESS, LEAD (N=2) DIPLOPIA/BLURRED VISION, LEAD (N=2) LIGHTHEADEDNESS, LEAD (N=1) BLEPHAROSPASM, LEAD (N=1) CONFUSION, LEAD (N=1) MUTISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION DEVICES MHY MEDTRONIC NEUROMODULATION 3387 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR IMPLANTABLE PULSE GENERATOR| IMPLANTABLE PULSE GENERATOR