BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMABLADE 4.0

    MDR report key: 6155052 · Received December 8, 2016

    Report

    Report Number
    1226420-2016-00188
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 8, 2016
    Report Date
    March 31, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 EXCHANGE, THE SURGEON ACTIVATED THE PLASMABLADE DEVICE CAUSING THE PATIENT TO GO INTO CARDIAC ARREST. THE PATIENT WAS DEFIBRILLATED ONCE AND WENT BACK INTO A NORMAL RHYTHM. THE PATIENT DID NOT REQUIRE ANY FURTHER INTERVENTIONS. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

    Description of Event or Problem · 1

    DURING A PACEMAKER EXCHANGE, THE SURGEON ACTIVATED THE PLASMABLADE DEVICE CAUSING THE PATIENT TO GO INTO CARDIAC ARREST. THE PATIENT WAS DEFIBRILLATED ONCE AND WENT BACK INTO A NORMAL RHYTHM. THE PATIENT DID NOT REQUIRE ANY FURTHER INTERVENTIONS. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805296 PLASMABLADE 4.0 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS200-040 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention