BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822273 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00184
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS REC'D BY THE MFR FOR THE TIME PERIOD 08/15/2010 THROUGH 08/15/2012. EVAL: THE GENERATOR AND A NON-OEM POWER CORD AND USER'S MANUAL WERE RETURNED. THERE WERE NO ERROR 4 IN THE LOG, HOWEVER, THE LOG DID SHOW THERE WERE NORMAL USE ERROR CODES EXCEPT FOR F6 CODE. THIS FAULT OCCURS WHEN COMMUNICATION BETWEEN THE UCB AND RF CONTROLLER GETS GARBLED. FOR SAFETY REASONS THE SYSTEM SHUTS OFF AND REQUIRES POWER CYCLE BEFORE IT WILL DELIVER RF ENERGY. THE APPLICABLE HARDWARE AND SOFTWARE UPGRADES WERE PERFORMED AND THE UNIT PASSED FINAL TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FAILURE OCCURRED DURING A SPINAL FUSION PROCEDURE; THE PULSAR CONTROLLER SOUNDED AN ALARM AND DISPLAYED ERROR 4 ON THE SCREEN. THE CONTROLLER WAS ALLOWED TO REST AND THE PROCEDURE RESUMED. AFTER A FEW MINS OF USE, THE ERROR 4 ALARM SOUNDED AGAIN. THE UNIT WAS SHUT DOWN AND RESTARTED AND ONLY WORKED BRIEFLY. THIS HAPPENED 4 TIMES AND THE SURGEON ABANDONED THE PLASMABLADE AND SWITCHED TO A CONVENTIONAL ELECTROSURGICAL DEVICE. THERE WERE NO OTHER ELECTROSURGICAL DEVICES USED IN CLOSE PROXIMITY TO PEAK; A SURGE PROTECTOR WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR GENERATOR GEI MEDTRONIC ADVANCED ENERGY LLC PULSAR GENERATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE