BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 1960095 · Received December 17, 2010

    Report

    Report Number
    1811755-2010-02088
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K032601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED, BUT NOT YET REC'D FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE MADE IF THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    DURING A RHIZOTOMY PROCEDURE, THE PRODUCT FAILED TO WORK. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND BACKUP EQUIPMENT WAS NOT AVAILABLE. THE PT HAD ALREADY BEEN GIVEN A LOCAL ANESTHETIC WHEN IT WAS DECIDED TO CANCEL THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF MULTIGEN GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK