BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTIO

    MDR report key: 4850287 · Received June 11, 2015

    Report

    Report Number
    MW5043097
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    INNOVATIVE SURGICAL SOLUTIONS
    Product Code
    PDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MINOR BURN FROM SENTIO MMG STIMULATOR NOTED ON PT RIGHT BUTTOCK FROM GROUNDING PAD WHEN DRAPES REMOVED. WHEN PT WAS ROLLED OVER ON TO BED FROM JACKSON TABLE A LARGE BLACK NECROTIC BURN NOTED ON PT LEFT ANTERIOR THIGH. THE WIRE FROM THE SENSOR THAT WAS PLACED ON HER THIGH HAD CAME LOOSE AND WAS TOUCHING HER LEFT THIGH. SURGEON HAD ALREADY LEFT THE ROOM WHEN THE BURNS WERE DISCOVERED. HE WAS IMMEDIATELY NOTIFIED. THE SENTIO MMG STIMULATOR WAS TAKEN OUT OF SERVICE. DURING THE SURGERY A GREEN LIGHT WITH WORD GO IN A CIRCLE WAS NOTED WITH WORDS STIMULATING UNDER IT. THEN RED CIRCLE WHICH SAID STOP AND NOT STIMULATING. THE SURGEON AWARE OF THIS DURING THE SURGERY. NEW STIMULATOR PROBE WAS OPENED. STIMULATOR MACHINE TURNED OFF THEN TURNED BACK ON BY STRYKER SPINE REP WHO WAS TROUBLESHOOTING THE SENTIO MMG STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380987 SENTIO SENTIO PDQ INNOVATIVE SURGICAL SOLUTIONS MMG 200013, 200015, 21002, 21003

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other