BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1950337 · Received December 14, 2010

    Report

    Report Number
    6000153-2010-10476
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 30, 2010
    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).

    Description of Event or Problem · 1

    RECEIVED INFO, THE PHYSICIAN OPENED A STERILE PACKAGE DURING SURGERY AND NOTICED THE TIP OF THE LEAD WAS CURVED. THE GUIDING WIRE WAS REMOVED AND CHECKED, BUT IT WAS THE LEAD ITSELF THAT WAS THE PROBLEM. ANOTHER LEAD WAS USED AND IMPLANTED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MVD LEAD MHY MPROC, VILLALBA 3387 V8281383

    Patients

    Seq Age Sex Outcome Treatment
    1