BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3173679 · Received June 17, 2013

    Report

    Report Number
    3007566237-2013-02004
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD STALLED. IT WAS NOTED THAT THE PHYSICIAN SCHEDULED THE PATIENT FOR SURGERY RIGHT AWAY. IT WAS STATED THAT THE PATIENT WAS ADMITTED BECAUSE ¿HERS WAS REALLY BAD¿, WHICH WAS UNCLEAR IN MEANING, BUT WAS SEEMINGLY A REFERENCE TO THE PATIENT¿S SYMPTOMS. THE SURGERY HAD BEEN PERFORMED ON THE NEXT DAY. LATER THAT SAME DAY, IT WAS REPORTED THAT THE PUMP HAD STALLED ¿OUT OF THE BLUE¿. THE DRUG USED IN THIS SYSTEM WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273043 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R