BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING DRIVE SYSTEM

    MDR report key: 3966154 · Received June 27, 2014

    Report

    Report Number
    3005677147-2014-00002
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 25, 2014
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K011775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMANCE CHECK AND COMPATIBILITY CHECK WITH THE LEKSELL FRAME AT THE USER FACILITY DID NOT FIND ANY DEVIATIONS OUTSIDE OF TOLERABLE LIMITS.

    Description of Event or Problem · 1

    DURING A DEEP BRAIN STIMULATION (DBS) PROCEDURE PERFORMED AT (B)(6), THE USER REPORTED TO FHC'S DISTRIBUTOR ((B)(4)) AN ISSUE WITH THE TARGETING OF THE FHC MICRODRIVE AND ADAPTER. PROF (B)(6) STARTED THE SURGERY WITHOUT X-RAY. THE RESULTS OF THE MICROELECTRODE RECORDING (MER) WERE NOT GOOD, SO HE MADE AN X-RAY IMAGE USING THE GRID INSTRUMENTS FOR THE LEKSELL FRAME. A DEVIATION FROM THE PLANNED TRAJECTORY WAS NOTED. THERE WAS NO PATIENT IMPACT, HOWEVER THE SURGERY WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375782 MICROTARGETING DRIVE SYSTEM STEREOTACTIC MICRODRIVE SYSTEM HAW FHC, INC. 9033G0601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention