BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP

    MDR report key: 3232977 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02394
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN A PUMP WHERE THE ¿GEARS WENT OUT¿. THE DRUG USED IN THE DEVICE SYSTEM WAS UNKNOWN. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333906 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1