BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINIX

    MDR report key: 3141936 · Received April 3, 2013

    Report

    Report Number
    3141936
    Event Type
    Other
    Date Received
    April 3, 2013
    Date of Event
    December 18, 2012
    Report Date
    April 3, 2013
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH REDNESS AND IRRITATION ON LEFT ARM SEVERAL DAYS AFTER RASH. PROCEDURE WAS EP STUDY WITH MAPPING AND RF ABLATION FOR WOLFF-PARKINSON-WHITE SYNDROME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EP STUDY WITH MAPPING AND RF ABLATION FOR WOLFF-PARKINSON-WHITE SYNDROME.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137776 INFINIX SYSTEM, X-RAY, CATH/ANGIO JAA TOSHIBA AMERICA MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other STOCKERT GENERATOR, PHYSIO-CONTROL LIFEPAK 20