BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 1040048 · Received May 7, 2008

    Report

    Report Number
    6000030-2008-02423
    Event Type
    Injury
    Date Received
    May 7, 2008
    Report Date
    April 9, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P8600004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS HAVING DECREASED EFFICACY. A ROTOR STUDY WAS NEGATIVE. THE CATHETER STUDY REVEALED THE SPINAL SEGMENT HAD BACKED OUT OF THE SPINAL SEGMENT. THERE WAS ALSO A COLLECTION OF DYE AROUND THE CONNECTOR PIN. NO DYE REACHED THE TIP OF THE CATHETER. X-RAY REVEALED THE ENTIRE SPINAL SEGMENT TO BE LOCATED IN THE SUBCUTANEOUS SPACE. THE PT WILL EVENTUALLY HAVE A REVISION OF THIS CATHETER AND A REPOSITIONING OF THE PUMP (ROTATE THE PUMP 180 DEGREES SO THAT THE CAP POINTS TOWARDS THE MIDLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATHECAL CATHETER LKK RICE CREEK MANUFACTURING UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 8637 LOT# UNK| NOT CONFIRM| CATHETER MODEL THOUGHT TO BE 8731| IMPLANTED: