InjuryIPF

PULSETTO FIT

Received Jan 8, 2026 · Event occurred Dec 30, 2025

Report MW5181966 · MDR key 24009149

Device

Generic name

Stimulator, Muscle, Powered

Manufacturer

Uab Pulsetto

Model number

PLST-FIT

Patient

58 YR · Male

Headache
Tinnitus

Narrative

Description of Event or Problem

I USED THE PULSETTO VARGAS NERVE STIMULATOR. IT WAS AT A LOW LEVEL (3-4), AND I DEVELOPED A HEADACHE, AND ALSO CAUSED MY TINNITUS TO FLARE-UP. IT HASN'T GONE AWAY. I HAVE LIVED WITH TINNITUS FOR ~8 YEARS AND HAVEN'T HAD THIS LONG OR INTENSITY OF FLARE-UP EVER.