BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND XT 4CH COMBO PKG

    MDR report key: 2001036 · Received February 21, 2011

    Report

    Report Number
    1022819-2011-00002
    Event Type
    Injury
    Date Received
    February 21, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 18, 2011
    Product Code
    IPF
    PMA / PMN Number
    K953615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S INVESTIGATION OF THE RETURNED DEVICE AND ACCESSORIES REVEALED THAT ALL 4 ELECTRODE PADS TESTED AROUND 200 OHMS RESISTANCE, AND WERE DRY WITH VERY LITTLE ADHESION, THE UNIT AND APPLICATORS WERE ABLE TO GENERATE THE DESIRED SIGNALS. THE INTELECT LEGEND XT USERS MANUAL WARNS THAT SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES ARE EXPECTED ADVERSE EVENTS, AND THE DURA-STICK ELECTRODES ARE SINGLE PT USE PRODUCT FOR INTELECT LEGEND XT. ALSO, DURA-STICK PACKAGING CONTAINS THE INSTRUCTIONS FOR PT SKIN PREPARATION, ELECTRODE INSPECTION PRIOR TO EACH USE, AND SUGGESTED NUMBER OF USES. THE DEVICE ALSO COMES WITH CONDUCTIVE GELS THAT COULD IMPROVE ELECTRICAL CONDUCTIVITY AND MOISTURE FOR ELECTRODE ADHESIVITY. IT IS MOST LIKELY THAT THE DRY AND LOW ADHESIVITY PADS WITH HIGH RESISTANCE CAUSES THE SECOND DEGREE BURNS AND THE PADS ARE FROM THE MFR NOT RECOMMENDED IN CHATTANOOGA USERS MANUAL.

    Description of Event or Problem · 1

    THERE ARE ONLY TWO PTS ATTACHED TO THE MACHINE AND USING ELECTRICAL STIMULATION AT THE SAME TIME. ONLY ONE PT WAS INJURED. PT IS A MALE, (B)(6) YRS OLD, WEIGHS APPROXIMATELY 175 LBS. NO PRE-EXISTING CONDITIONS NOTED OTHER THAN A LEFT CALCANEAL FRACTURE WITH OPEN REDUCTION INTERNAL FIXATION. PT STATED THAT HE FELT A BURNING UNDER ONE OF THE PADS AND ASKED TO TURN THE INTENSITY DOWN ON THE SETTINGS. INTENSITY WAS TURNED DOWN TO PT'S COMFORT LEVEL ONCE AGAIN. THERE WERE NO FURTHER COMPLAINTS FROM THE PT. THE DATA THE PT RECEIVED THE INJURY WAS ON (B)(6) 2011. OINTMENT TREATMENT WAS GIVEN TO DECREASE PAIN COMPLAINTS AND TO IMPROVE PT'S TOLERANCE TO STANDING AND WALKING. INTERFERENTIAL CURRENT SET UP IN THE USUAL CRISS CROSS PATTERN WAS USED FOR ELECTRICAL STIMULATION TREATMENT AT 80-150 HZ FOR 15 MINS AT AN INTENSITY OF 38 MA WITH A COLD PACK TO THE TREATMENT AREA. PT HAD TWO SECOND DEGREE BURNS ON THE MEDIAL ASPECT OF HIS LEFT FOOT, ONE LARGER THAN THE OTHER, OVER THE NAVICULAR BONE APPROXIMATELY 1 CM IN DIAMETER AND ANOTHER AT THE ACHILLES TENDON REGION APPROXIMATELY 0.5 CM. THE SIZE OF THE ELECTRODES ARE 2 INCHES BY 2 INCHES SQUARE MFG BY DYNA FLEX POLY ADHESIVE. THE ELECTRODES WERE USED 18 TIMES. THE PT HAD USED INTERFERENTIAL CURRENT IN THE PAST FOR 17 TIMES WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 4CH COMBO PKG ELECTROTHERAPY IPF 2788 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other