BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 1000729 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00760
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    July 7, 2006
    Report Date
    August 11, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004/S54
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER ANALYSIS REVEALED NO ANOMALIES, NORMAL DEVICE FUNCTION. THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    THE HCP REPORTED THE PATIENT WAS NOT GETTING THE NEEDED SPASTICITY RELIEF. THE PUMP WAS EXPLANTED AND REPLACED AFTER AN IMPLANT DURATION OF 6 MONTHS. ADDITIONAL INFORMATION FROM THE HCP REPORTED THE PATIENT WAS EXPERIENCING INCREASED SPASTICITY AND PAIN. THE HCP REPORTED HE "WENT THROUGH EVERYTHING DIAGNOSTICALLY INCLUDING MYELOGRAM THROUGH PUMP ACCESS PORT. AT SURGERY, CATHETER (DISTAL) WAS WRAPPED IN ARACHNOID AND WAS NOT FUNCTIONING." THE CATHETER WAS EXPLANTED AND REPLACED. THE PATIENT WAS REPORTED TO HAVE RECOVERED WITHOUT SEQUELA. REFERENCE MANUFACTURER REPORT: 2182207-2006-01391.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATHECAL CATHETER LKK RICE CREEK MANUFACTURING 8731 N002170012

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention EXPLANTED| CATHETER MODEL 8596| IMPLANTED