BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3202915 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01024
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    September 18, 2012
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE OUTER PACKAGE OF AN INTRATHECAL CATHETER MODEL 8731SC, THE LABELING REPORTED THE CORRECT MODEL NUMBER ON ONE SIDE AND THE INCORRECT MODEL NUMBER 87831SC ON THE OTHER SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300832 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8731SC 0204925267

    Patients

    Seq Age Sex Outcome Treatment
    1