BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2220010 · Received August 9, 2011

    Report

    Report Number
    6000153-2011-06197
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    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

    IT WAS REPORTED THAT AFTER SECURING THE LEAD IN STIMLOC THE LEAD WAS INTERNALIZED BEFORE THE SECOND STAGE OF THE OPERATION. WHEN THE IMPLANTING HCP REOPENED THE SKIN AND UNTIED THE SCREWS OF THE TEMPORARY LEAD CAP THE DISTAL CONNECTION WAS FOUND DAMAGED. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MPROC, VILLALBA 3387 V419056

    Patients

    Seq Age Sex Outcome Treatment
    1