BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD

    MDR report key: 2081414 · Received April 22, 2011

    Report

    Report Number
    6000153-2011-03001
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    April 12, 2010
    Report Date
    December 1, 2010
    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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT AN IMPLANT PROCEDURE, WHEN THE LEAD WAS OPENED, ELECTRODES 0 AND 1 APPEARED "OUT OF ALIGNMENT". THE PHYSICIAN DID NOT FEEL COMFORTABLE USING THE LEAD AND A NEW LEAD WAS IMPLANTED. THERE WERE NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MPROC, VILLALBA 3389S-40 V435220

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR