BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD

    MDR report key: 2251045 · Received September 8, 2011

    Report

    Report Number
    6000153-2011-07590
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    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

    IT WAS REPORTED THAT THE LEAD WAS BENT UPON OPENING THE PACKAGE. THE PHYSICIAN USED A RULER TO MEASURE, AND THE LEAD WAS BENT 2-3 MM IN THE MIDDLE PART OF THE LEAD. A NEW LEAD WAS USED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MPROC, VILLALBA 3389S-40 V671225

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR