BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N'VISION

    MDR report key: 1001781 · Received February 19, 2008

    Report

    Report Number
    2182207-2008-00802
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Report Date
    January 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP HAS BEEN PROGRAMMED WITH A 250 MCG/ML CONCENTRATION AT 20 MCG/DAY WITH A FLOW RATE OF .08 ML/DAY. HOWEVER, THE NURSE WAS CERTAIN THAT THE PUMP HAD CONTAINED 500 MCG/ML FOR OVER A YR RATHER THAN THE 250 MCG/ML CONCENTRATION THAT WAS PROGRAMMED, SO THE PT WAS ACTUALLY RECEIVING 40 MCG/DAY. THE PUMP WAS LAST FILLED IN 2007 AND IT WAS THOUGHT THAT THE PUMP MAY HAVE BEEN RUNNING AT THE MINIMUM RATE SINCE 2007, SO IT WAS POSSIBLE THE PT HAD NOT BEEN RECEIVING THE PROGRAMMED AMOUNT OF DRUG SINCE 2007, BUT THE PT HAD NOT EXPERIENCED ANY WITHDRAWAL OR OVERDOSE SYMPTOMS. THE PLAN WAS TO REPROGRAM THE PUMP WITH THE CORRECT CONCENTRATION AND ADJUST THE PT'S DOSE ACCORDINGLY. THE HCP FURTHER REPORTED THAT THE PT'S PUMP WAS USED TO DELIVER LIORESAL. THE FINAL PT OUTCOME WAS REPORTED AS "NO INJURY".

    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 EXPLANTED:| IMPLANTED:| CATHETER MODEL 8731 LOT# N001609313| IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863720| LOT# NGP008512N| EXPLANTED: