BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1040544 · Received May 9, 2008

    Report

    Report Number
    6000030-2008-02519
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 10, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD LEG WEAKNESS AND/OR SPASM. THE PT ALSO FELT NUMBNESS AND TINGLING IN HIS FEET, HANDS, LEGS, ARMS AND TORSO. THE PT HAD EXTREME PAIN IN HIS FEET. THE SYMPTOMS STARTED SEVERAL MONTHS AGO. THE PT WAS AT HOME AND HIS STATUS WAS FAIR. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8711 J10976R37

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PUMP MODEL #863740| IMPLANTED| PROGRAMMER MODEL 8840| EXPLANTED