BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3241357 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02432
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPORTER HAD ¿SEEN A REAL FAILURE, MAYBE ONE OR TWO IN 12 YEARS," WHEN REFERRING TO THE PUMP. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340307 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1