BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1052989 · Received May 27, 2008

    Report

    Report Number
    6000030-2008-02810
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT, WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S SPASTICITY HAD RETURNED. THE HEALTH CARE PROVIDERS WERE UNABLE TO ACCESS DRUG FROM THE SIDE PORT. THERE WAS OCCLUSION AND THE CATHETER WAS REPLACED. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 J11661R25

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention LOT# NGV410808H| IMPLANTABLE INFUSION PUMP MODEL 863740| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK