BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3201646 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00927
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    January 9, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE LAST REFILL, ONLY HEALTH CARE PROVIDER (HCP) COULD ONLY PULL BACK HALF THE FLUID THAT WAS SUPPOSED TO BE REMOVED. ONLY 20 MILLILITERS OF COULD BE PUT IN THE PUMP AND NOT ¿THE OTHER 40.¿ THE BELLOWS HAD STUCK ON THE PUMP AND HE HAD TO HAVE IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301652 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention