BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOBLATE G2

    MDR report key: 1730468 · Received June 15, 2010

    Report

    Report Number
    2135394-2010-00009
    Event Type
    Injury
    Date Received
    June 15, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    OCL
    PMA / PMN Number
    K080509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ANALYSIS: NO PRODUCT WAS RETURNED FOR ANALYSIS. HOWEVER, BASED ON AN INVESTIGATION INTO THIS EVENT, THE GENERATOR'S WATTAGE SETTING WAS NOT RETURNED TO THE CUSTOMER'S ORIGINAL SETTING (25 WATTS) AND THE POWER CORD WAS NOT PLUGGED IN. ADDITIONALLY, NORMAL PROCEDURAL STEPS (GENERAL SETTINGS CHECK, SALINE CHECK, AND GAUZE TEST) WERE NOT PERFORMED PRIOR TO THIS PROCEDURE. THESE STEPS ARE PART OF THE SET UP PROCEDURE REQUIREMENT AND WOULD HAVE CAUGHT THE WATTAGE SETTING CHANGE. AN IN-SERVICE WAS SCHEDULED TO REVIEW THE RECOMMENDED SET UP AND WATTAGE SETTINGS WITH THE CUSTOMER. CONCLUSION: IN CONCLUSION, THIS EVENT WAS CAUSED BY OPERATIONAL CONTEXT. MEDTRONIC WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THAT SHORTLY AFTER SERVICE OF THIS CARDIOBLATE GENERATOR, THE PHYSICIAN ATTEMPTED TO USE THE UNIT. IT WAS DISCOVERED THAT THE UNIT WAS NOT PLUGGED IN. AFTER PLUGGING IN THE UNIT, THE PHYSICIAN IRRIGATED AN XL PEN AND WHEN ATTEMPTING TO ABLATE THE POSTERIOR LEFT ATRIAL WALL HEARD A VERY LOUD "POP", AND A PERFORATION OF THE POSTERIOR ATRIAL WALL WAS DISCOVERED. IT WAS NOTED THAT THE WATTAGE OF THE GENERATOR WAS SET AT 50. THE PERFORATION WAS REPAIRED. THE REMAINDER OF THE CASE WAS PERFORMED WITHOUT FURTHER COMPLICATION WITH A DIFFERENT GENERATOR. THE MEDTRONIC SERVICE TECHNICIAN CONFIRMED THAT DURING SERVICE OF SEVERAL PRODUCTS, HE WAS ASKED TO SWITCH ROOMS. THE SERVICE TECHNICIAN OMITTED TO FORGETTING TO CHANGE THE SETTINGS BACK TO THE CUSTOMER'S SETTINGS, AND NOT PLUGGING IN THE GENERATOR AFTER SERVICING WAS COMPLETE. IT WAS LATER REPORTED THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOBLATE G2 OCL MEDTRONIC PERFUSION SYSTEMS 68000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R