MalfunctionQGT

NERIVIO INFINITY

Received Apr 3, 2026 · Event occurred Mar 19, 2026

Report 24778455 · MDR key 24778455

Device

Generic name

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Manufacturer

Theranica Bio-electronics Ltd

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

OUR OFFICE RECEIVED A PATIENT SAFETY REPORT INVOLVING A MEDICAL DEVICE, NERIVIO INFINITY, WHICH EXPLODED WHILE CHARGING. THE EVENT CAUSED DAMAGE TO THE PATIENTS CARPET BUT RESULTED IN NO INJURIES. PROVIDERS HAVE BEEN INSTRUCTED NOT TO ORDER ANY NERIVIO DEVICES. EVENT DESCRIPTION: PATIENT WAS USING A NERIVIO INFINITY DEVICE FOR HEADACHE RELIEF. THE DEVICE EXPLODED WHILE CHARGING AND CAUSED CARPET BURNS. MANUFACTURER: THERANICA BIO-ELECTRONICS. MODEL: NERIVIO INFINITY.