BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203548 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-01118
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    August 31, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED REGARDING A PUMP. PATIENT REPORTED THAT A GENTLEMAN AT THE COURTHOUSE (ANOTHER MORPHINE PUMP PATIENT) SAID EVERY TIME HE GOES THROUGH SECURITY DETECTORS, LIKE GETTING ON A CRUISE OR, OR GOING IN A COURT HOUSE, HIS PUMP SPEEDED UP. A FOLLOW UP WAS NOT POSSIBLE AT THE MOMENT OF THIS REPORT SINCE THE INFORMATION ON THE PATIENT (GENTLEMAN AT THE COURT HOUSE) WAS NOT AVAILABLE. SYSTEM USED TO DELIVER MORPHINE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304792 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1