BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1995930 · Received February 16, 2011

    Report

    Report Number
    3007566237-2011-01161
    Event Type
    Injury
    Date Received
    February 16, 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). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PATIENT INFORMATION PROVIDED IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING DEVICE, THE EVENT AND PATIENT 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. DECEMBER 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 FOLLOW-UP AFTER BILATERAL SUBTHALAMIC DBS. REPORTABLE EVENT: IN ONE PATIENT UNDERGOING BILATERAL PALLIDAL DBS UNDER GENERAL ANESTHESIA, STEREOTACTIC MRI REVEALED A MEDIAL DEVIATION OF THE LEFT ELECTRODE FROM THE INTENDED ANATOMIC TARGET WITH ENCROACHMENT ON THE INTERNAL CAPSULE. IMMEDIATE RELOCATION OF THIS ELECTRODE WAS PERFORMED FOLLOWED BY A NEW POSTOPERATIVE STEREOTACTIC MRI.

    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 LEAD: MODEL 3387, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| IMPLANTED: