BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEX GENERATOR

    MDR report key: 6000838 · Received October 5, 2016

    Report

    Report Number
    1226420-2016-00140
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K143175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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

    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 INADVERTENTLY DAMAGED THE SILICON CASING ON A PACEMAKER LEAD WHILE USING A PLASMABLADE DEVICE. THE SURGEON WAS ABLE TO REPAIR THE LEAD CASING. THE FUNCTIONALITY OF THE LEAD WAS NOT AFFECTED AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650810 AEX GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 40-405-1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention