BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR PULSAR II

    MDR report key: 4029648 · Received August 22, 2014

    Report

    Report Number
    1226420-2014-00071
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD/RESULTS/CONCLUSION: GENERATOR STILL IN USE AND FACILITY NOT RETURNING FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    DURING A PACEMAKER GENERATOR EXCHANGE PROCEDURE THE PLASMABLADE WAS ACTIVATED AND THE PACEMAKER STOPPED PACING SUCH THAT THE PATIENT DID NOT HAVE A HR. THE STRIP FROM EXTERNAL DEFIBRILLATOR SHOWED THAT THE PACEMAKER WAS TRYING TO PACE BUT THERE WAS NO OUTPUT. PLASMABLADE ACTIVATION WAS CEASED AND AFTER APPROXIMATELY 30-40 SECONDS THE PACEMAKER OUTPUT AND PATIENT'S HR RETURNED TO A NORMAL RATE (PATIENT IS PACEMAKER DEPENDENT). TEMPORARY PACING WAS AVAILABLE BUT NOT UTILIZED AS PACEMAKER OUTPUT AND PATIENT HR RECOVERED BEFORE THE TEMPORARY SYSTEM COULD BE UTILIZED (30-40 SECONDS). SURGEON CONTINUED THE CASE WITH A SCALPEL FOR DISSECTION AND NO FURTHER ISSUES OCCURRED. SURGEON USED THE PLASMABLADE AGAIN AFTER THE NEW ST. JUDE PACEMAKER WAS IMPLANTED AND ACTIVATION OF THE PLASMABLADE DID NOT IMPACT PACEMAKER FUNCTIONALITY. ST. JUDE VICTORY PACEMAKER THAT WAS REPLACED WAS AT THE ERI (ELECTIVE REPLACEMENT INTERVAL). ST JUDE HAS RELEASED A DOCUMENT STATING THAT ELECTROSURGERY MAY HAVE AN IMPACT TO THE FUNCTIONALITY OF OLDER MODEL ST. JUDE PACEMAKERS AND RECOMMENDS NO ELECTROSURGERY DEVICES TO BE USED. REFERENCE LINK: HTTP://PROFESSIONAL.SJM.COM/PROFESSIONAL/RESOURCES/PRODUCT-P ERFORMANCE/PACEMAKER-012914-COMMUNICATION/PHYSICIAN-COMMUNICATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508128 GENERATOR PULSAR II GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR