BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203555 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-01006
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    October 10, 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 THERE HAVE BEEN SEVERAL PATIENTS WHO HAVE MISSED THEIR REFILL DATES AND THE PUMPS HAVE BEEN EMPTY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306445 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1