BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1022899 · Received March 28, 2008

    Report

    Report Number
    6000030-2008-01636
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 26, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    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 THAT DURING BACK SURGERY, THE CATHETER WAS CUT; THE SURGEON REPLACED THE CATHETER WITH A "SHUNT CATHETER". IT IS UNK IF THE CATHETER WAS CUT THAT DAY OR IF IT WAS CUT PREVIOUSLY. NO PT SYMPTOMS WERE REPORTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 L78722

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863740| LOT # NGV0227772| PROGRAMMER MODEL 8841| EXPLANTED: