BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD

    MDR report key: 2101730 · Received May 10, 2011

    Report

    Report Number
    6000153-2011-03358
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960004
    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

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN NOTED THAT THE DISTAL TIP OF THE LEAD HAD A SIGNIFICANT CURVE TO IT STRAIGHT OUT OF THE BOX. THE LEAD WAS NOT USED IN THE PATIENT AND A NEW LEAD WAS THEN IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MPROC, VILLALBA 3389S-40 V561099

    Patients

    Seq Age Sex Outcome Treatment
    1