BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 3140859 · Received May 22, 2013

    Report

    Report Number
    1717344-2013-00374
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 17, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT PAD WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVAL. THE E7506 INSTRUCTIONS FOR USE WARNS THAT NON-TRADITIONAL PROCEDURES THAT UTILIZE HIGH CURRENT, LONG DUTY CYCLES, OR BOTH (FOR EXAMPLE: TISSUE LESIONING, TISSUE ABLATION, TISSUE VAPORIZATIONS, AND PROCEDURES IN WHICH CONDUCTIVE FLUIDS SUCH AS SALINE OR LACTATED RINGER'S SOLUTION ARE INTRODUCED INTO THE SURGICAL SITE FOR DISTENTION OR TO CONDUCT THE RF CURRENT) INCREASE THE RISK OF EXCESSIVE HEATING UNDER A FULLY APPLIED RETURN ELECTRODE TO THE POINT OF INJURING THE PT. USE OF MORE THAN ONE RETURN ELECTRODE MAY HELP MITIGATE THE INCREASED RISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT RECEIVED A 2ND-3RD DEGREE BURN AT THE PAD SITE DURING A CARDIAC ABLATION PROCEDURE. THE PAD HAD BEEN PLACED ON THE PT'S RIGHT LATERAL ASPECT OF THE CHEST WALL. THE INJURY WAS DESCRIBED A 0.25% DEPTH, FULL THICKNESS BURN WITH SURROUNDING ERYTHEMA. DURING THE PROCEDURE, THE PT WAS RESTLESS AND THE PAD LIFTED FROM THE PT'S SKIN. THE PAD WAS REAPPLIED AND NO INJURY NOTED AT THE TIME. THE BURN WAS TREATED WITH THE SILVADENE, FOLLOWED BY DEBRIDEMENT A WEEK LATER. THE INCIDENT PAD WAS DISCARDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227271 POLYHESIVE RETURN ELECTRODE PATIENT RETURN ELECTRODE GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other