BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSITE MULTI-ELECTRODE ARRAY CATHETER

    MDR report key: 1151324 · Received September 4, 2008

    Report

    Report Number
    2184149-2008-00010
    Event Type
    Injury
    Date Received
    September 4, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ST. JUDE MEDICAL, ESI
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL IS AWAITING DEVICE RETURN. ONCE THE ANALYSIS HAS BEEN COMPLETED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS BURNED ON THE SKIN WHERE THE NAVX REFERENCE PATCH WAS PLACED. THE PHYSICIAN DOES NOT ALLEGE BURN WAS CAUSED BY THE NAVX PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE MULTI-ELECTRODE ARRAY CATHETER ARRAY CATHETER DRF ST. JUDE MEDICAL, ESI NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK