BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAIT MYOELECTRIC STIMULATOR II

    MDR report key: 3759728 · Received April 14, 2014

    Report

    Report Number
    MW5035699
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    January 14, 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 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 MUSCLE TO CONTRACT AT THE CORRECT TIME TO MOVE THE LEG PROPERLY FOR WALKING EFFICIENCY. THE STIMULATION WAS PROVIDED THROUGHOUT THE DAY (6-8 HOURS) WHENEVER THE CHILD WAS WALKING AND TURNED OFF AUTOMATICALLY WHEN THE CHILD WAS INACTIVE. THE CHILD HAD BEEN WEARING THE STIMULATION SYSTEM FOR 3 WEEKS WHEN A SKIN RASH DEVELOPED UNDER ONE OF THE PADS STIMULATING THE PLANTAR FLEXOR MUSCLES. THE PADS WERE REMOVED AND STIMULATION WAS DISCONTINUED. THE PRINCIPAL INVESTIGATOR NOTIFIED THE (B)(4) OF THIS EVENT. THE (B)(4) COMMITTEE DETERMINED THE CHILD SHOULD BE REMOVED FROM THE STUDY. THE STUDY WAS SUSPENDED DUE TO A TOTAL OF 4 CHILDREN WHO DEVELOPED A SIMILAR SKIN IRRITATION. DATES OF USE: (B)(6) 2013 TO (B)(6) 2014. REASON FOR USE: CEREBRAL PALSY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227235 GAIT MYOELECTRIC STIMULATOR II GMES II MKD GMES II

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR