BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2023456 · Received March 8, 2011

    Report

    Report Number
    6000153-2011-01744
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 22, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFO IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    THE ELECTRODE WAS FOUND TO BE BROKEN WHEN THE CUSTOMER TRIED TO PLACE THE BOOT OVER THE LEAD. THE LEAD WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MPROC, VILLALBA 3389 0203966377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown