BEUDAMED
    FDA Adverse Event Death Summary report: N

    15CM PERCUTANEOUS ANTENNA X1

    MDR report key: 6341732 · Received February 17, 2017

    Report

    Report Number
    3006451981-2017-00182
    Event Type
    Death
    Date Received
    February 17, 2017
    Date of Event
    December 23, 2016
    Report Date
    January 23, 2017
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN
    Product Code
    NEY
    PMA / PMN Number
    K133821
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(4). DATE OF INITIAL REPORT: (B)(6) 2017. THE CUSTOMER HAS INDICATED THAT SAMPLES WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. 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 THE PATIENT DIED DUE TO A SEVERE INFLAMMATORY RESPONSE AFTER A LIVER ABLATION. THE CASE HAD GONE SMOOTHLY WITH NO TEMPERATURE ALARMS THROUGHOUT. THE CUSTOMER INDICATED THAT THERE WAS NO FAILURE OF THE GENERATOR OR THE ABLATION ANTENNA. NEITHER WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122713 15CM PERCUTANEOUS ANTENNA X1 PERCUTANEOUS ABLATION ANTENNA NEY COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN CA15L1 S6CG001X

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death ABLATION GENERATOR (B)(4)