BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2246529 · Received September 6, 2011

    Report

    Report Number
    3007566237-2011-07456
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    May 21, 2009
    Report Date
    August 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PT INFO PROVIDED IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PTS AND DEVICES HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: SMEDING HMM, SPEELMAN JD, HUIZENGA HM, SCHUUMAN PR, SCHMAND B. PREDICTORS OF COGNITIVE AND PSYCHOSOCIAL OUTCOME AFTER STN DBS IN PARKINSON'S DISEASE. J NEUROL NEUROSURG PSYCHIATRY.2011;82(7):754-760. DOI 10.1136/JNNP.2007. 140012. SUMMARY: THE AUTHORS EXAMINED PREDICTORS OF COGNITIVE DECLINE AND QUALITY OF LIFE 1 YEAR AFTER BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN DBS) IN PARKINSON'S DISEASE (PD). A TOTAL OF 105 PTS WERE EVALUATED WITH A COMPREHENSIVE NEUROPSYCHOLOGICAL ASSESSMENT BEFORE AND 12 MONTHS AFTER SURGERY. A CONTROL GROUP OF 40 PD PTS WAS INCLUDED TO CONTROL FOR EFFECTS OF REPEATED TESTING AND DISEASE PROGRESSION. REPORTABLE EVENT: THE AUTHORS REPORTED THAT NORMATIVE COMPARISONS METHOD REVEALED THAT 38 OUT OF THE 105 STN PTS SHOWED COGNITIVE DECLINE, WHICH IS A PATTERN OF TEST RESULTS THAT DEVIATED SIGNIFICANTLY AND IN A NEGATIVE DIRECTION FROM THE CONTROL GROUP. ONE STN PT HAD A PALLIDOTOMY DURING THE F/U INTERVAL, TWO PTS HAD A DISLOCATED ELECTRODE, AND TWO PTS SUFFERED A POSTOPERATIVE HEMORRHAGE. AFTER 12 MONTHS, SIX PTS FROM THE STN GROUP WERE LOST TO F/U; TWO HAD AN INFECTION OF THE STIMULATOR.

    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 58 YR Other LEADS: MODEL 3389 LOT# UNK| EXPLANTED:| IMPLANTED: