BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED CANNULA, 100MM, 20G, 10MM, DISPOSABLE, 10/PACKAGE

    MDR report key: 3972761 · Received August 1, 2014

    Report

    Report Number
    0001811755-2014-02743
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    March 1, 2014
    Report Date
    July 22, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXI
    PMA / PMN Number
    K032406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED AS THE DISPOSITION OF THE DEVICE IS UNKNOWN BY THE USER FACILITY; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED MALFUNCTION WITHOUT AN EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 WEEKS FOLLOWING A SUCCESSFUL, "UNEVENTFUL" RF DENERVATION PROCEDURE, THE PATIENT CAME IN TO AN OUTPATIENT FACILITY WITH A "SMALL SINUS IN THE AREA OF COCCYX." IT WAS REPORTED THAT "THE LESION WAS WELL DEMARCATED AND NOT INFECTED AND THAT THE PATIENT WAS ON ANTIBIOTICS" IT WAS ALSO REPORTED THAT "THE CAUSE OF SINUS IS UNKNOWN AND THAT HE SUSPECTED AN RF BURN". IT WAS REPORTED THAT BUPIVACAINE 0.25% ALONG WITH DEPO-MEDRONE 20 MG WAS INJECTED TO REDUCE THE DISCOMFORT AND THAT THE PATIENT WAS DISCHARGED. IT WAS REPORTED THAT THE PATIENT HAS BEEN REFERRED FOR AN MRI SCAN OF THE COCCYGEAL REGION AND TO A PLASTIC SURGEON FOR AN OPINION. IT WAS REPORTED THAT, "THE PATIENT WILL BE SEEN SOON IN FOLLOW UP CLINIC WHERE FURTHER INFORMATION ABOUT THE PATIENT STATUS CAN BE GATHERED." A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450709 CURVED CANNULA, 100MM, 20G, 10MM, DISPOSABLE, 10/PACKAGE PROBE, RADIOFREQUENCY LESION GXI STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 Other MULTIGEN RF GENERATOR 0406900000 (LES6482)| NITINOL ELECTRODE 0406-815-010 (UNKNOWN)