BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE GROUNDING PAD W/CABLE

    MDR report key: 6707105 · Received July 12, 2017

    Report

    Report Number
    2182269-2017-00075
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 15, 2017
    Report Date
    July 12, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PATIENT BURN COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A LEFT LUMBAR ABLATION, A PATIENT BURN OCCURRED. THE GROUNDING PAD WAS PLACED ON THE RIGHT FLANK ABOVE THE ILIAC CREST AND WAS PREPPED ON A PATIENT THAT WAS NEITHER HAIRY OR DIAPHORETIC. A SECOND DEGREE BUR WAS NOTED WHERE THE GROUNDING PAD WAS APPLIED. THE BURN WAS DRESSED WITH SILVER SULFADIAZINE CREAM AND ORAL PAIN MEDICATION WAS ADMINISTERED. THERE WERE NO PERFORMANCE ISSUES WITH AN ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487260 DISPOSABLE GROUNDING PAD W/CABLE DISPOSABLE GROUNDING PAD GXD ST. JUDE MEDICAL, INC. RF-DGP-S 20170118

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other NEUROTHERM GENERATOR