InjuryNUH

TENS UNIT

Received Jun 1, 2026

Report MW5188696 · MDR key 25347121

Device

Generic name

Stimulator, Nerve, Transcutaneous, Over-the-counter

Manufacturer

Tenscare Ltd.

Patient

NA · Unknown

Insufficient Information

Narrative

Description of Event or Problem

PATIENT MENTIONED BEFORE THEY HAD THE STIMULATOR IMPLANTED, THEY WOULD USE AN EXTERNAL TENS UNIT THAT SOMETIMES/EVENTUALLY STOPPED WORKING. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).