BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA CATHETER

    MDR report key: 1052567 · Received May 22, 2008

    Report

    Report Number
    6000030-2008-02735
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NEVER EXPERIENCED A THERAPEUTIC EFFECT FROM THE DEVICE EVEN AFTER INCREASED DOSAGE. THE DRUG IN THE PUMP WAS DILAUDID 20.0 MG/ML AT A DOSE OF 5.996 MG/DAY AND BUPIVACAINE 2.1 MG/ML AT A DOSE OF 0.6296 MG/DAY. THE HCP PERFORMED A CATHETER DYE STUDY AND COULD NOT ASPIRATE THE CATHETER. A BOLUS WAS THEN FORCED THROUGH THE CATHETER WITHOUT ANY SYMPTOMS OF OVERDOSE. THE HCP NOTED A VOLUME DISCREPANCY EXPECTING TO PULL BACK 5ML AND PULLED BACK 20 ML. TWO ROLLER STUDIES WERE PERFORMED RESULTING IN THE FIRST STUDY ROLLERS WERE NOT SEEN TURNING, BUT WERE TURNING ON THE SECOND STUDY. AN MRI WAS CONDUCTED WITH RESULTS INDICATING THE CATHETER TIP WAS AT T8-9, BUT THE TIP WAS NOT SEEN WELL. THERE WAS NO EVIDENCE OF A MASS WITHIN THE SUBARACHNOID OR EPIDURAL SPACES TO SUGGEST GRANULOMA FORMATION. NO FINDINGS OF ASSOCIATED OSTEOMYELITIS OR NEOPLASM. THE HCP THUS SUSPECTED A KINKED CATHETER. A REVISION WAS SCHEDULED TO CORRECT THE ISSUE. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION 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 CATHETER LKK RICE CREEK MANUFACTURING 8709 L71601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXLANTED:| IMPLANTED:| PROGRAMMER MODEL 8840| IMPLANTABLE PUMP MODEL 863720