BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD

    MDR report key: 2193596 · Received July 14, 2011

    Report

    Report Number
    6000153-2011-05454
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    March 22, 2010
    Report Date
    May 6, 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): 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 THE ISSUE INVOLVED A LEAD; CONTACT "0" WAS OUT OF ALIGNMENT WITH OTHER CONTACTS - "BENT". THE COMPONENT WAS REPLACED. THE DEVICE WAS NOT USED WITH /IN PATIENT. NO PT INJURY WAS NOTED. THE PT OUTCOME WAS RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MPROC, VILLALBA 3389S-40 V411494

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR