BEUDAMED
    FDA Adverse Event Death Summary report: N

    15CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5112077 · Received September 29, 2015

    Report

    Report Number
    1717344-2015-00679
    Event Type
    Death
    Date Received
    September 29, 2015
    Date of Event
    May 22, 2014
    Report Date
    September 2, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS NOT RETURNED TO COVIDIEN FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR 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 PATIENT IN HER 70'S BEING TREATED FOR PNEUMONIA WITH FLUID IN HER LUNGS, WAS ADMITTED TO HOSPITAL WITH RESPIRATORY DISTRESS. A LUNG ABLATION WAS PERFORMED. THE ABLATION WAS COMPLETED AS EXPECTED WITHOUT COMPLICATIONS. A FEW DAYS POST PROCEDURE A LATENT PNEUMOTHORAX WAS OBSERVED. A CHEST TUBE WAS PLACED AND THE PNEUMOTHORAX RESOLVED IN ABOUT 2 DAYS AND THE CHEST TUBE WAS REMOVED. ABOUT 2 WEEKS LATER, THE PATIENT WAS SYMPTOMATIC. IMAGING FEATURES SHOWED BI-LOBAR PNEUMONITIS. THE PATIENT DIED SOON AFTER. PHYSICIAN STATED CAUSE OF DEATH WAS COMORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642266 15CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LP CA15L1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death