InjuryIPF
NEXWAVE TENS/IFC UNIT
Received Feb 4, 2014 · Event occurred Jan 20, 2014
Report MW5034212 · MDR key 3612642
Device
Product problems
- Device Operates Differently Than Expected
Patient
44 YR
- Therapeutic Effects, Unexpected
- Shock from Patient Lead(s)
Narrative
Description of Event or Problem
WAS DISPENSED A ZYNEX MEDICAL NEXWAVE TENS/IFC UNIT (B)(4) FOR TREATMENT OF BACK PAIN. THE UNIT HAS REPEATEDLY BEEN DELIVERING FAR HIGHER SHOCKS THAN ACCORDING TO PROGRAM IN TENS MODE, A POWERFUL SHOCK ABOUT EVERY TEN MINS COMPLETELY OUT OF LINE WITH WHAT SHOCKING STIMULATION WAS DELIVERED DURING OTHER PERIODS. ZYNEX REQUESTED RETURN OF THE UNIT FOR REPLACEMENT. DATES NOTED WERE (B)(6), 2014.