BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3201278 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01041
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    September 1, 2011
    Report Date
    September 23, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    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 AT A REFILL APPOINTMENT THE PHYSICIAN ASPIRATED 20 ML OF MEDICINE FROM THE PUMP. A DYE STUDY WAS SCHEDULED. THE EXPECTED RESERVOIR VOLUME WAS 1.5 ML. THERE WERE NO PATIENT SYMPTOMS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300540 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1