BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 4649860 · Received April 1, 2015

    Report

    Report Number
    1226420-2015-00047
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 2, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT (B)(4) EVALUATION PROCESS: *PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. UNIT IS IN GOOD CONDITION. PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. NO PERFORMANCE ISSUES FOUND. DELIVERED RF ENERGY PROPERLY IN ALL MODES. ROOT CAUSE: SERVICE DEPARTMENT COULD NOT REPLICATE THE CUSTOMER¿S COMPLAINT. (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/COMPONENT EXCHANGE PROCEDURE UTILIZING THE PULSAR SYSTEM, IT WAS IDENTIFIED THAT THE SYSTEM ACTIVATION TONE CONTINUED UPON RELEASE OF THE COAG ACTIVATION BUTTON. IT IS UNKNOWN IF ENERGY WAS STILL BEING DELIVERED TO THE DEVICE OR NOT. NO ISSUES WERE REPORTED REGARDING THE CUT FUNCTION. A SECOND DEVICE FROM THE SAME UNKNOWN LOT AND A THIRD DEVICE FROM A KNOWN LOT WERE USED FOR TROUBLESHOOTING AND THE SAME ISSUE PERSISTED THEREFORE AN ADDITIONAL GENERATOR WAS UTILIZED TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    DURING A PACEMAKER GENERATOR/COMPONENT EXCHANGE PROCEDURE UTILIZING, THE PULSAR SYSTEM, IT WAS IDENTIFIED THAT THE SYSTEM ACTIVATION TONE CONTINUED UPON RELEASE OF THE COAG ACTIVATION BUTTON. IT IS UNKNOWN IF ENERGY WAS STILL BEING DELIVERED TO THE DEVICE OR NOT. NO ISSUES WERE REPORTED REGARDING THE CUT FUNCTION. A SECOND DEVICE FROM THE SAME UNKNOWN LOT AND A THIRD DEVICE FROM A KNOWN LOT WERE USED FOR TROUBLESHOOTING AND THE SAME ISSUE PERSISTED THEREFORE AN ADDITIONAL GENERATOR WAS UTILIZED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214714 PULSAR II GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR