BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3201389 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00352
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS LOSING THERAPEUTIC EFFECT. SYSTEM TROUBLESHOOT WAS BEING CONDUCTED, AND THE PHYSICIAN WAS UNABLE TO DRAW FROM THE CATHETER ACCESS PORT. A DYE STUDY WAS NOT PREFORMED DUE TO THIS ISSUE, BUT AND (B)(6) STUDY WAS GOING TO BE CONDUCTED. 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
    303144 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1