BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3202658 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00516
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS IN THE ICU FOR PNEUMONIA, THE PATIENT ¿WILL BE NEEDING A PUMP REFILL VERY SOON¿. LATER ON THE SAME DAY IT WAS REPORTED THAT ¿NOW IT¿S RUN OUT AND WE DON¿T HAVE ANYTHING TO REFILL IT WITH¿. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302316 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1