BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD

    MDR report key: 2193402 · Received July 13, 2011

    Report

    Report Number
    6000153-2011-05407
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    March 4, 2011
    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 COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING IMPLANT SURGERY, THE PHYSICAL TIP OF THE LEAD'S ELECTRODE APPEARED "BULBOUS" AND OUT OF ALIGNMENT. THE LEAD WAS NOT USED IN THE PT AND A NEW LEAD WAS USED WITHOUT FURTHER ISSUE REPORTED. THERE WAS NO INJURY TO THE PT AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MPROC, VILLALBA 3389S V409757

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK