BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD KIT

    MDR report key: 2193404 · Received July 13, 2011

    Report

    Report Number
    6000153-2011-05404
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    October 14, 2010
    Report Date
    May 6, 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): THE LEAD HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING IMPLANTATION SURGERY, THE LEAD CONTACT 0 WAS OUT OF ALIGNMENT WITH THE OTHER CONTACTS. THE LEAD WAS NOT USED AND A NEW LEAD WAS USED WITHOUT FURTHER ISSUE REPORTED. THERE WAS NO INJURY TO THE PT AND THE PT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD KIT MHY MPROC, VILLALBA 3387S V451316

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK