BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD (RIGHT SIDED)

    MDR report key: 1051109 · Received May 22, 2008

    Report

    Report Number
    6000153-2008-02741
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    September 22, 2005
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEMONSTRATED SIGNIFICANT COGNITIVE DECLINE FOLLOWING BILATERAL SUBTHALAMIC NUCLEUS LEAD PLACEMENT. POSTOPERATIVE IMAGING OF THE RIGHT-SIDED LEAD DETECTED SUBOPTIMAL LEAD POSITION WITHIN THE BRAIN; THERE WERE REPORTED SYMPTOMS OF IMPAIRMENT IN EXECUTIVE FUNCTIONING AND MEMORY LOSS AFTER COMPLETION OF THE CASE. THE PATIENT UNDERWENT FORMAL NEUROPSYCHOLOGICAL EVALUATION APPROXIMATELY ONE YEAR LATER, WHICH REVEALED SIGNIFICANT DECLINES IN COGNITIVE FUNCTION, RELATIVE TO RESULTS OBTAINED FROM PATIENT ASSESSMENT PRIOR TO LEAD REPLACEMENT. THERE WAS IMPAIRMENT REPORTED IN THE AREAS OF ATTENTION AND INFORMATION PROCESSING SPEED, EXECUTIVE FUNCTIONING, LEARNING AND MEMORY OF VERBAL AND VISUAL MATERIAL, VERBAL FLUENCY, READING COMPREHENSION, VISUOSPATIAL FUNCTIONING, AND BILATERAL FINE MOTOR COORDINATION. THE CURRENT PATIENT STATUS AND DEVICE DISPOSITION WERE UNKNOWN; THE LEAD WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE TRACKING SYSTEM DOES NOT INDICATE SYSTEM REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD (RIGHT SIDED) MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387 J0546531V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHU091282V| IMPLANTED:| LEAD MODEL 3387 LOT# J0546531V| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7426| LOT# NFW129889H| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED:| LOT# NFW130569H| IMPLANTED: