BEUDAMED
    FDA Adverse Event Other Summary report: N

    JACE TRI-STIM

    MDR report key: 80369 · Received March 27, 1997

    Report

    Report Number
    80369
    Event Type
    Other
    Date Received
    March 27, 1997
    Date of Event
    May 29, 1996
    Report Date
    October 15, 1996
    Manufacturer
    THERALABS, INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEING SEEN FOR INITIAL EVAL. TWO ELECTRODES (CHANNEL 1) WERE PLACED ON HAMSTRING, AND TWO ELECTRODES (CHANNEL 2) WERE PLACED ON QUADS. STIMULATOR WAS TURNED ON AND INTENSITY WAS INCREASED TO 32MA ON CHANNEL 1, AND TO 60MA ON CHANNEL 2. SUDDENLY, THE STIMULATOR BEGAN TO OPERATE; CHANNEL 1 CAME ON AND THEN AS CHANNEL 2 CAME ON, PT YELLED "OUCH" AND EXPERIENCED A STRONG QUAD CONTRACTION WHICH WAS ALSO OBSERVED. (PREVIOUSLY, THE PT COULD NOT PERCEIVE ANY SENSATION ON CHANNEL 2). THE STIMULATOR WAS THEN SHUT OFF AND REMOVED FROM SERVICE, AND RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACE TRI-STIM TRI-STIM IPF THERALABS, INC. THERALAB 16173 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other