BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1031339 · Received April 18, 2008

    Report

    Report Number
    6000030-2008-02080
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    AS PART OF A ROUTINE PUMP REPLACEMENT SURGERY, A CATHETER DYE STUDY WAS DONE TO CHECK CATHETER PATENCY. THE CATHETER WAS FOUND TO BE BLOCKED. THE CATHETER WAS REPLACED. THERE WAS NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP/CATHETER WAS NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8703W L44301

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR IMPLANTED:| EXPLANTED:| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| PUMP MODEL 8627L18 SERIAL# NGH018430R