BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N'VISION

    MDR report key: 1031335 · Received April 18, 2008

    Report

    Report Number
    2182207-2008-02061
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DRUG CONCENTRATION WAS INCREASED FROM 10 MG/ML TO 25 MG/ML. NO BRIDGE BOLUS WAS PERFORMED. THE FAILURE TO PROGRAM THE BRIDGE BOLUS WAS NOTED 4.5 HOURS AFTER THE PROGRAMMING CHANGE. THE PT WAS REPROGRAMMED TO CORRECT FOR THE ERROR. THE PT WAS FINE AND HAD NO EFFECT FROM THE PROGRAMMING ERROR. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM INDICATES IT IS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N'VISION LKK MEDTRONIC NEUROMODULATION 8840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709SC LOT# N112489016| IMPLANTED:| IMPLANTED:| LOT# NGP308986H| IMPLANTABLE INFUSION PUMP MODEL 863720| EXPLANTED:| EXPLANTED: