BEUDAMED
    FDA Adverse Event Death Summary report: N

    15CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5112179 · Received September 29, 2015

    Report

    Report Number
    1717344-2015-00680
    Event Type
    Death
    Date Received
    September 29, 2015
    Date of Event
    December 29, 2014
    Report Date
    September 2, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 09/29/2015. THE INCIDENT DEVICE WAS NOT RETURNED TO COVIDIEN FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LUNG ABLATION WAS PERFORMED ON THE PATIENT. THE ABLATION WAS COMPLETED AS EXPECTED WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED AND DIED AT HOME 2 DAYS LATER WITHOUT SYMPTOM. THE PHYSICIAN STATED THIS PATIENT WAS SALVAGE POST RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643080 15CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LP CA15L1

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death