BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3201393 · Received July 2, 2013

    Report

    Report Number
    3007566237-2012-03101
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    October 1, 2011
    Report Date
    February 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT HAD DRUG INSIDE THEIR PUMP SINCE (B)(6) OF 2011. IF THE HEALTH CARE PROVIDER (HCP) DECIDED TO REFILL THE PATIENT, THEY WERE GOING TO DO IT WITH THE SAME CONCENTRATION OF DRUG AT A LOW DOSAGE INITIALLY. IT WAS NOT UNKNOWN WHAT DRUG WAS BEING DELIVERED BY THE DEVICE SYSTEM. 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
    303294 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1