BEUDAMED
    FDA Adverse Event Summary report: N

    GAIT MYOELECTRIC STIMULATOR II

    MDR report key: 3757121 · Received April 11, 2014

    Report

    Report Number
    MW5035668
    Date Received
    April 11, 2014
    Date of Event
    January 4, 2014
    Report Date
    March 5, 2014
    Product Code
    MKD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS PT WITH CEREBRAL PALSY WAS THE SECOND CHILD ENROLLED IN A STUDY TO ASSESS THE BENEFITS OF SURFACE ELECTRICAL STIMULATION TO IMPROVE WALKING. WATER BASED ELECTRODES WERE USED TO CONDUCT THE CURRENT FROM THE STIMULATOR TO THE SKIN WHICH CAUSED HER PLANTAR FLEXOR AND DORSIFLEXOR MUSCLES TO CONTRACT AT THE CORRECT TIME TO MOVE THE LEG PROPERLY FOR WALKING EFFICIENCY. THE STIMULATION WAS PROVIDED THROUGHOUT THE DAY (6-8 HRS) WHENEVER THE CHILD WAS WALKING AND TURNED OFF AUTOMATICALLY WHEN THE CHILD WAS INACTIVE. THE CHILD HAD BEEN WEARING THE STIMULATION SYSTEM FOR 4 WEEKS WHEN HER MOTHER SENT A TEXT MESSAGE ON (B)(6) 2014 WITH PICTURES SHOWING THAT A SKIN IRRITATION HAD DEVELOPED UNDER ONE OF THE PADS STIMULATING THE PLANTAR FLEXOR MUSCLES. THE CHILD AND HER MOTHER CAME TO THE NEXT AVAILABLE APPOINTMENT ON (B)(6) 2014 TO ASSESS THE SKIN ISSUE. THE SKIN WAS SLIGHTLY PINK. THE MOTHER WAS INSTRUCTED NOT TO RE-APPLY THE PADS AND THEREFORE, NOT TO RESUME STIMULATION UNTIL THE SKIN HAD COMPLETELY HEALED. MOTHER DETERMINED THE SHIN HAD HEALED COMPLETELY ON (B)(6) 2014 AND RESUMED THE STUDY PROTOCOL. AT THE END OF THAT DAY, THE SKIN IRRITATION HAD REAPPEARED. MOTHER CALLED THE PRINCIPAL INVESTIGATOR FOR CONSULTATION AND WAS INSTRUCTED TO DISCONTINUED THE STIMULATION, REMOVE THE PADS, AND SCHEDULED A FOLLOW APPOINTMENT ON (B)(6) 2014. WITH CONCERN FOR THE CHILD'S SKIN INTEGRITY, THE STIMULATION WAS DISCONTINUED AND PADS WERE NOT REAPPLIED. THE PRINCIPAL INVESTIGATOR NOTIFIED THE (B)(4) OF THIS EVENT. THE (B)(4) COMMITTEE DETERMINED THE CHILD SHOULD BE REMOVED FROM THE STUDY. EVENTUALLY, THE STUDY WAS SUSPENDED DUE TO A TOTAL OF 4 CHILDREN WHO DEVELOPED A SIMILAR SKIN IRRITATION. THE SKIN IRRITATION BEGAN TO IMPROVE ONCE THE PADS WERE REMOVED. AS INSTRUCTED, THE MOTHER ONLY REAPPLIED THE PADS AND STIMULATION AFTER THE SKIN HAD COMPLETELY HEALED (BASED ON VISUAL INSPECTION) AFTER 7 DAYS. THE SKIN IRRITATION RETURNED AT THE END OF THAT DAY AND THE STIMULATION WAS DISCONTINUED. THE SKIN RETURNED TO A HEALTHY COLOR WITHIN 14 DAYS. DATES OF USE: (B)(6) 2013 TO (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: HEMIPLEGIA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION. FACILITY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220316 GAIT MYOELECTRIC STIMULATOR II GMES II MKD GMES II

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR