BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE GROUNDING PAD W/OUT CABLE

    MDR report key: 7722433 · Received July 26, 2018

    Report

    Report Number
    2182269-2018-00093
    Event Type
    Injury
    Date Received
    July 26, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 26, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, NO LOT NUMBER WAS PROVIDED TO A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED BURN MAY HAVE BEEN DUE TO THE WRINKLE IN THE PATCH. PER THE IFU, FAILURE TO ACHIEVE GOOD SKIN CONTACT BY THE ENTIRE SURFACE OF THE GROUNDING PAD MAY RESULT IN SIGNIFICANT ELECTROSURGICAL BURNS AT THE PAD LOCATION.

    Description of Event or Problem · 1

    DURING A THREE LEVEL UNILATERAL CERVICAL ABLATION PROCEDURE, A PATIENT BURN OCCURRED NEAR THE RIGHT FLANK UNDER THE GROUNDING PAD SITE. THE GENERATOR WAS ABLATING AT 80 DEGREES FOR 90 SECONDS. THERE WAS A WRINKLE ON THE GROUNDING PAD AND WHEN IT WAS REMOVED A SMALL BLISTER WAS NOTED. NO INTERVENTION WAS NEEDED TO TREAT THE BURN BUT THE PROCEDURE WAS CANCELLED. THE PATIENT IS IN STABLE CONDITION AND THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565640 DISPOSABLE GROUNDING PAD W/OUT CABLE PROBE, RADIOFREQUENCY LESION GXD ST. JUDE MEDICAL, INC. RF-DGP-L

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other