BEUDAMED
    FDA Adverse Event Death Summary report: N

    AEX GENERATOR

    MDR report key: 6011891 · Received October 7, 2016

    Report

    Report Number
    1226420-2016-00143
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    August 12, 2016
    Report Date
    September 8, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K143175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4) PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    AFTER A PACEMAKER EXCHANGE, THE SURGEON REPORTED A POCKET HEMATOMA POST-OPERATIVELY. THE SURGEON STATED IT WAS DIFFICULT TO STOP THE OOZING IN THE POCKET DURING SURGERY AND THE PLASMABLADE DEVICE MAY HAVE CONTRIBUTED TO THE HEMATOMA. THE PATIENT WENT BACK TO THE OPERATING ROOM TO EVACUATE THE HEMATOMA AND LATER DEVELOPED AN INFECTION AT THE SURGERY SITE. THE PATIENT WAS TRANSFERRED TO A SECOND FACILITY AND WENT BACK THE OPERATING ROOM FOR A LEAD EXTRACTION. THE SURGEON REPORTED THE PATIENT PASSED AWAY SHORTLY AFTER THE THIRD SURGERY. THE TIME OF DEATH IS UNKNOWN, BUT IS ESTIMATED AROUND 10 DAYS AFTER THE FIRST SURGERY. THE SURGEON REPORTED THE PATIENT HAD MULTIPLE COMORBIDITIES AND WAS ON BLOOD THINNER DURING THE FIRST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661775 AEX GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 40-405-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death