H-WAVE E STIMULATOR
Received Nov 21, 2000 · Event occurred Oct 20, 2000
Report MW1020473 · MDR key 305832
Device
Generic name
H-wave E Stimulator
Manufacturer
Electronic Wave Form, Lab Inc.Model number
PT-ACatalog number
*
Lot number
*
Product problems
- Electrical /Electronic Property Problem
- Reaction
Patient
24 YR
- Muscle Spasm(s)
- Seizures
- Loss of consciousness
Narrative
Description of Event or Problem
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.