BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD

    MDR report key: 2030190 · Received March 7, 2011

    Report

    Report Number
    6000153-2011-01687
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 20, 2011
    Manufacturer
    MPROC VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AT IMPLANT THE DOCTOR WAS LOCKING THE CLIP PIECE THAT WAS USED WITHIN THE NAVIGUS BASE CAP, AND THE CLIP WOULD NOT STAY LOCKED APPROPRIATELY. IT WAS REMOVED FROM THE FIELD AND SUBSEQUENTLY USED AN ACCESSORY KIT (B)(4) THAT WORKED. THERE WAS NO DAMAGE OR DISPLACEMENT TO THE LEAD. EVERYTHING WAS IMPLANTED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MPROC VILLALBA 3389S-40 V587361

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL STIMLOC, LOT# 082221410A