BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5233709 · Received November 18, 2015

    Report

    Report Number
    3006451981-2015-00284
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 4, 2015
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. 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 THEY EXPERIENCED TEMPERATURE UNSTABLE ALERTS DURING AN ABLATION PROCEDURE. THE ABLATION WAS FINISHED BUT THEY WERE UNABLE TO PERFORM A TRACT ABLATION. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763172 15CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA LPB COVIDIEN LLC (SHANGHAI) CA15L1 S5GG002X

    Patients

    Seq Age Sex Outcome Treatment
    1