BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA CATHETER

    MDR report key: 804057 · Received December 28, 2006

    Report

    Report Number
    6000030-2006-02379
    Event Type
    Malfunction
    Date Received
    December 28, 2006
    Date of Event
    November 20, 2006
    Report Date
    November 27, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    p860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL ANALYSIS INFORMATION REPORTS THE CATHETER WAS RECEIVED IN 4 SECTIONS. IN 2 OF THE CATHETER SECTIONS, ABRASIONS WERE PRESENT, AND IN 1 CATHETER SECTION, IT WAS REPORTED TO BE DEFORMED.

    Description of Event or Problem · 1

    THE HCP REPORTED THE INTRATHECAL CATHETER WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS DUE TO "OCCLUSION." SPECIFIC PATIENT SYMPTOMS, AND POSSIBLE DEVICE TROUBLESHOOTING PRIOR TO REPLACEMENT SURGERY WERE NOT REPORTED BY THE HCP. THE HCP DID REPORT THE PATIENT HAD RECOVERED WITHOUT SEQUELA AFTER THE CATHETER WAS REMOVED AND REPLACED. SEE MANUFACTURER REPORT # 6000030-2006-02377.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK LKK RICE CREEK MANUFACTURING 8709 L71604

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization PUMP MODEL # 8627L18, LOT#NA, IMPLANTED| EXPLNATED