InjuryQHH
IB-STIM
Received Jun 24, 2025 · Event occurred Jun 10, 2025
Report MW5171884 · MDR key 22329095
Device
Generic name
Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome
Manufacturer
Neuraxis IncProduct problems
- Patient Device Interaction Problem
Patient
14 YR · Male
- Sleep Dysfunction
- Sleep Dysfunction
Narrative
Description of Event or Problem
MY SON HAD AN IRRITABLE BOWEL SYNDROME- STIMULATOR DEVICE PLACED ON (B)(6) 2025. SINCE THAT TIME, HE HAS HAD SERIOUS SLEEP DISTURBANCES. THE IB-STIM IS APPARENTLY DISRUPTING HIS CIRCADIAN RHYTHMS AND HE HAS HAD VERY LITTLE SLEEP IN THREE DAYS. THIS SIDE EFFECT WAS NOT DISCLOSED IN THE INFORMED CONSENT THAT WE SIGNED.