BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N'VISION

    MDR report key: 1040043 · Received May 7, 2008

    Report

    Report Number
    2182207-2008-02427
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT UNDERWENT A CATHETER ACCESS PORT PROCEDURE WHICH REVEALED THE CATHETER WAS NOT IN THE INTRATHECAL SPACE. THE FOLLOWING MORNING, DURING A CATHETER REVISION, THE PT EXPERIENCED RESPIRATORY DEPRESSION, SIGNIFICANT DROWSINESS, AND WAS NON-RESPONSIVE FOLLOWING AN ADD'L BOLUS OF 398 MCG WHEN THE VOLUME FOR THE PUMP TUBING WAS ADDED TO THE BOLUS AMOUNT. THE PT WAS ADMITTED TO THE CRITICAL CARE UNIT FOR MONITORING AND THE PUMP WAS SET AT THE MINIMUM RATE. THE PT'S STATUS WAS REPORTED TO BE STABLE, BUT SHE WAS EXPERIENCING INCREASED SPASTICITY, REQUIRING A LIORESAL DOSAGE INCREASES. THE PT WAS AT HOME AND 'DOING OK.' NO FOLLOW UP APPOINTMENT WAS SCHEDULED AT THAT TIME.

    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 Hospitalization| L| R EXPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863720| CATHETER MODEL 8731SC LOT# N135123031| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NGP310198H