BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 999827 · Received February 13, 2008

    Report

    Report Number
    1717344-2008-00049
    Event Type
    Malfunction
    Date Received
    February 13, 2008
    Date of Event
    December 21, 2007
    Report Date
    February 12, 2008
    Manufacturer
    COVIDIEN (VALLEY LAB)
    Product Code
    ODR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE SAMPLE, A DETAILED INVESTIGATION COULD NOT BE PERFORMED. THE CUSTOMER REPORTED THAT THE PAD MAY BE FROM THE FOLLOWING LOT NUMBERS: 114886, 121271, 122454. THE DEVICE HISTORY RECORD (DHR) INDICATES THE LOT NUMBERS REPORTED WERE RELEASED, MEETING ALL QA SPECIFICATIONS. A CHANGE HAS BEEN MADE TO THE E7506 INSTRUCTIONS FOR USE (IFU) TO ADD A WARNING THAT PROCEDURES THAT UTILIZE HIGH CURRENT AND/OR LONG DUTY CYCLES (SUCH AS TISSUE ABLATION) INCREASE THE RISK OF EXCESSIVE HEATING TO THE POINT OF INJURING THE PT. USE OF MORE THAN ONE PAD MAY HELP MITIGATE THE INCREASED RISK. BOSTON SCIENTIFIC WAS FORWARDED THIS INFO.

    Description of Event or Problem · 1

    END OF THE PROCEDURE THE GROUND PAD WAS BEING REMOVED AND NOTICED THE PT WAS INJURED (BURNED). BURN WAS NOT CLASSIFIED BUT REPORTED TO BE 1CM X 4CM AND IT WAS REPORTED THAT OINTMENT WAS USED AND PT WAS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE RETURN ELECTRODE ELECTROSURGERY PAD ODR COVIDIEN (VALLEY LAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CATHETER BLAXER XP (4790THK2)| BOSTON SCIENTIFIC GENERATOR