BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 4501346 · Received February 10, 2015

    Report

    Report Number
    1226420-2015-00030
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Date of Event
    January 15, 2015
    Report Date
    May 22, 2015
    Manufacturer
    MEDTRONIC ADVANCE ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION PROCESS: *PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -NO ISSUES FOUND. UNIT IS IN GOOD CONDITION. *PERFORMED BASELINE FUNCTION TESTING PER TCL-514-900008. -NO PERFORMANCE ISSUES FOUND UNIT DELIVERED RF ENERGY PROPERLY IN ALL MODES. -THERE WERE NO ISSUES ENCOUNTERED WHILE PLUGGING IN A HANDPIECE. ROOT CAUSE: THE 2 CUSTOMER COMPLAINTS COULD NOT BE REPLICATED. THERE WERE NO ISSUES PLUGGING IN THE HANDPIECES. UNIT DELIVERED RF ENERGY PROPERLY IN ALL MODES.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). METHOD: PRODUCT SCHEDULED FOR RETURN BUT NOT YET RECEIVED BY MANUFACTURER FOR INSPECTION. RESULTS: PRODUCT SCHEDULED FOR RETURN BUT NOT YET RECEIVED BY MANUFACTURER FOR INSPECTION. EVAL CODE CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT YET RECEIVED BY MANUFACTURER FOR INSPECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A PACEMAKER GENERATOR EXCHANGE PROCEDURE THE SURGEON WAS USING THE PLASMABLADE AS PART OF A TRIAL. INITIAL SETTINGS WERE 5 CUT 6 COAG AND DURING USE OF THE PLASMABLADE IT WAS BELIEVED BY THE SURGEON THAT THE PLASMABLADE DAMAGED THE LV LEAD. LEAD WAS REPLACED WITH NO PATIENT IMPACT OR INJURY.

    Description of Event or Problem · 1

    DURING A PACEMAKER GENERATOR EXCHANGE PROCEDURE THE SURGEON WAS USING THE PLASMABLADE AS PART OF A TRIAL. INITIAL SETTINGS WERE 5 CUT 6 COAG AND DURING USE OF THE PLASMABLADE IT WAS BELIEVED BY THE SURGEON THAT THE PLASMABLADE DAMAGED THE LV LEAD. LEAD WAS REPLACED WITH NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97696 PULSAR II GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCE ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR