BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF GEN OBSOLETE REPLACED BY 0406900000

    MDR report key: 2469717 · Received February 17, 2012

    Report

    Report Number
    1811755-2012-00587
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 24, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K063489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A PT RETURNED FOR A F/U VISIT FOLLOWING A LUMBAR RADIOFREQUENCY ABLATION, THEY COMPLAINED OF INCREASED PAIN AND A SMALL AMOUNT OF SWELLING TO THE AREA. ACCORDING TO THE SURGEON, THERE WAS NO INDICATION OF PROBLEMS WITH DEVICE DURING THE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF GEN OBSOLETE REPLACED BY 0406900000 GXD STRYKER INSTRUMENTS KALAMAZOO LES4387

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK