BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1041272 · Received May 9, 2008

    Report

    Report Number
    6000030-2008-02517
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 10, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE FIRST REFILL AFTER THE PUMP WAS IMPLANTED, 19.5 MLS OF DRUG WERE EXTRACTED FROM THE PUMP RESERVOIR; THE EXPECTED VOLUME WAS 11 MLS. THE EVENT LOGS WERE REVIEWED AND NO ABNORMALITIES WERE DETECTED BY THE PUMP (SEE MANUFACTURER'S REPORT # 3004209178-2008-02454). BASED ON THIS, THE HCP THOUGHT THE PROBLEM WAS PROBABLY WITH THE CATHETER TRACT AND PLANNED TO DO FURTHER TESTING. THE PUMP WAS USED TO DELIVER BACLOFEN. THE PATIENT HAD NO CLINICAL SIGNS OF UNDERDOSE AND WAS FEELING WELL. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 J0033357R

    Patients

    Seq Age Sex Outcome Treatment
    1 PUMP MODEL 8637-20| EXPLANTED| IMPLANTED| CATHETER MODEL 8578 LOT# B0472646K| EXPLANTED| IMPLANTED