BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD

    MDR report key: 2081401 · Received April 22, 2011

    Report

    Report Number
    6000153-2011-03008
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    December 20, 2010
    Report Date
    February 1, 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). 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 DURING AN IMPLANT PROCEDURE, THE PHYSICIAN NOTICED ON THE LEAD THERE WAS A BEND AT ELECTRODE #0. THE LEAD WAS NOT IMPLANTED AND A NEW LEAD WAS THEN USED WITHOUT FURTHER INCIDENT. THERE WERE NO PATIENT INJURIES REPORTED. SEE ALSO MANUFACTURER REPORTS #6000153201103007 AND 6000153201103009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MPROC, VILLALBA 3389S-40 V589283

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR