BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_UNKNOWN_PUMP

    MDR report key: 3143018 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01838
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    February 21, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ISSUES ACCESSING THE PORT TO REFILL THE PUMP. THE HEALTH CARE PROFESSIONAL WAS TRYING TO ¿VISUALIZE THE NUMBERS ON THE PUMP¿ TO SEE IF THE PUMP WAS ¿SLIPPED.¿ IT WAS LATER REPORTED THAT IT WAS A BACLOFEN PUMP. THE PUMP HAD TO BE REVISED BECAUSE THE PUMP FLIPPED WHILE THE PATIENT WAS STILL IN THE HOSPITAL AFTER INITIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243399 NEU_UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention