BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-WAVE E STIMULATOR

    MDR report key: 305832 · Received November 21, 2000

    Report

    Report Number
    MW1020473
    Event Type
    Injury
    Date Received
    November 21, 2000
    Date of Event
    October 20, 2000
    Report Date
    November 14, 2000
    Manufacturer
    ELECTRONIC WAVE FORM, LAB INC.
    Product Code
    JPF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PHYSICAL THERAPY TREATMENT, WHILE LYING SUPINE, ON H-WAVE ELECTRICAL STIMULATOR TO NECK (POST) AND UPPER TRAPEZIUS (LOW), THE PT WAS HEARD MOANING. THE PT THEN FELL TO THE GROUND IN WHAT APPEARED TO BE A SEIZURE, EYE FLUTTER "EXTREMITY TONE," WAS UNRESPONSIVE FOR APPROX 10-15 MINS. BLOOD PRESSURE 155/90, HEART RATE 96. PHYSICIAN ADVISED THE PT BE REMOVED TO THE ER FOR EVALUATION. THE PT GRADUALLY REGAINED CONSCIOUSNESS PRIOR TO TRANSFER TO THE ER. TREATING NEUROLOGIST DIAGNOSIS OF MUSCLE CONTRACTION. NO KNOWN LASTING EFFECTS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-WAVE E STIMULATOR H-WAVE E STIMULATOR JPF ELECTRONIC WAVE FORM, LAB INC. PT-A *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR