MalfunctionBXN

SUNSTIM PERIPHERAL NERVE STIMULATOR/SUNSTIM PLUS PERIPHERAL NERVE STIMULATOR

Received Sep 17, 2024

Report MW5159678 · MDR key 20246318

Device

Generic name

Stimulator, Nerve, Battery-powered

Manufacturer

Easymed Instrumentation Co., Ltd.

Model number

8-1053-60

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CALLER STATES HE HAS THREE MODEL 8-1053-60 DEVICES THAT HAVE ISSUES. ONE IS NOT WORKING, TWO OF THEM HAVE A HOLE IN THEM NEAR BUTTONS/'TWITCH'. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORTS: MW5159676, MW5159677.