BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA CATHETER

    MDR report key: 1040511 · Received May 9, 2008

    Report

    Report Number
    6000030-2008-02492
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    December 6, 2007
    Report Date
    January 23, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING SEVERE SPASMS AND IN "WITHDRAWAL". AN X-RAY INDICATED THE CATHETER HAD DISCONNECTED. THE DEVICES WERE EXPLANTED. THE PT DEVELOPED A SKIN INFECTION POSTOPERATIVELY. THE PT WAS TREATED WITH ORAL MEDICATIONS AND WAS RE-IMPLANTED WITHOUT A PROBLEM ABOUT TWO WEEKS AFTER THE INITIAL REMOVAL. THE DRUG USED IN THE PUMP WAS LIORESAL. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention EXPLANTED| PUMP MODEL 8637| EXPLANTED| IMPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK