BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYHESIVE PATIENT RETURN ELECTRODE

    MDR report key: 2854257 · Received December 3, 2012

    Report

    Report Number
    3005099803-2012-05456
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K822572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2012-05452, 3005099803-2012-05453, 3005099803-2012-05454, 3005099803-2012-05455, AND 3005099803-2012-05457 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RF3000 RADIOFREQUENCY GENERATOR, (B)(6) PATIENT RETURN ELECTRODES, AND A LEVEEN STANDARD ELECTRODE WERE USED DURING A HEPATIC RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, BOTH OF THE PATIENT'S LEGS HAD BEEN AMPUTATED; THEREFORE, THE LOCATIONS OF THE FOUR GROUNDING PADS WERE IMPROVISED: TWO PADS WERE PLACED ON THE INNER THIGH AND TWO WERE PLACED ON THE BUTTOCKS. THE ABLATION WAS THEN PERFORMED AND COMPLETED USING ALL THE ORIGINAL DEVICES. FOLLOWING THE PROCEDURE, THE GENERAL PRACTITIONER (NOT THE ATTENDING PHYSICIAN) NOTED THAT THE PATIENT HAD RECEIVED SECOND DEGREE BURNS UNDER THE FOUR GROUNDING PADS. IT IS UNKNOWN IF/HOW THE BURNS WERE TREATED. IT WAS REPORTED THAT THE RF3000 RADIOFREQUENCY GENERATOR HAS BEEN USED SUCCESSFULLY IN PROCEDURES SINCE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE PATIENT RETURN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262191 234689X

    Patients

    Seq Age Sex Outcome Treatment
    1