BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2241043 · Received August 17, 2011

    Report

    Report Number
    6000153-2011-06487
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HCP OPENED THE LEAD HE NOTICED THAT THE DISTAL TIP WAS SLIGHTLY BENT. THE LEAD WAS ALSO REPORTEDLY SOMEWHAT THICKER THAN NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MPROC, VILLALBA 3389 V728909

    Patients

    Seq Age Sex Outcome Treatment
    1