BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2000231 · Received February 17, 2011

    Report

    Report Number
    3007566237-2011-01175
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (DYSARTHRIA). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PT INFO PROVIDED IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE DEVICE, THE EVENT AND PT OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: HOLL EM, PETERSEN EA, FOLTYNIE T, ET AL. IMPROVING TARGETING IN IMAGE-GUIDED FRAME-BASED DEEP BRAIN STIMULATION. NEUROSURGERY. DEC 2010; 67 (2 SUPPL OPERATIVE): 437-447. SUMMARY: PRE- AND POSTOPERATIVE STEREOTACTIC MAGNETIC RESONANCE IMAGES (MRI) WERE ANALYZED IN 165 PATIENTS WITH PARKINSON DISEASE (PD). THE PERPENDICULAR ERROR BETWEEN PLANNED TARGET COORDINATES AND ELECTRODE TRAJECTORY WAS CALCULATED GEOMETRICALLY FOR ALL 312 DBS ELECTRODES IMPLANTED. IMPROVEMENT IN MOTOR UNIFIED PD RATING SCALE III SUBSCORE WAS CALCULATED FOR THOSE PATIENTS WITH PD WITH AT LEAST 6 MONTHS OF F/U AFTER BILATERAL SUBTHALAMIC DBS. REPORTABLE EVENT: ONE PT EXPERIENCED A SMALL DELAYED SUPERFICIAL CORTICAL HEMORRHAGE WITH MILD POSTOPERATIVE DYSARTHRIA WHICH RESOLVED WITHIN 1 MONTH OF SURGERY AND WAS THOUGHT TO BE UNRELATED TO THE BLEED, AND PROBABLY RELATED TO IMMEDIATE POSTOPERATIVE EDEMA AROUND THE ELECTRODE TIP, GIVEN THAT THIS DYSARTHRIA COULD BE REPRODUCED BY HIGH-VOLTAGE STIMULATION ON LONG-TERM F/U. THERE WAS NO OTHER HEMORRHAGIC COMPLICATION IN THIS SERIES OF PATIENTS. SEE LITERATURE ARTICLE WITH MFR REPORT # 3007566237-2011-01161.

    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 51 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# UNKNOWN| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: