BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINECATH

    MDR report key: 1190306 · Received October 6, 2008

    Report

    Report Number
    1020279-2008-00263
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 2, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A RF PROCEDURE, AN UNCONVENTIONAL METHOD WAS USED IN COMPONENT PLACEMENT RESULTING IN BREAKAGE. FIVE CENTIMETERS OF THE CATHETER TIP REMAINED IN THE PT. PROCEDURE CONTINUED WITH NO FURTHER DELAYS OR INCIDENTS. PT WAS MADE AWARE OF INCIDENT AND NO PLANS WERE MADE TO REMOVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINECATH INTRADISCAL CATHETER GEI SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR