BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3202733 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01133
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    May 8, 2012
    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 A PATIENT IN (B)(6) THAT WAS TAKING DRUG OUT OF HIS PUMP AND HAD DISCREPANCIES EVERY SINGLE TIME. IT WAS A FEW YEARS AGO, AND THE MANUFACTURER¿S REPRESENTATIVE COULDN¿T REMEMBER THE PATIENT¿S NAME. THERE WAS NO SYMPTOM REPORTED AND THE DRUG IN THE PUMP WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301839 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1