BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2895226 · Received January 3, 2013

    Report

    Report Number
    3007566237-2013-00023
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP "WENT INTO FAILURE AND COMPLETELY STOPPED". IT WAS NOTED THAT THE PUMP WAS DUE TO BE CHANGED "PROBABLY IN THE NEXT 11 MONTHS" FROM THE DATE OF THE REPORT. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2934 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1