inforMED
MalfunctionGWE

CASCADE EMG/EP/EEG IOM

Received Sep 21, 2016 · Event occurred May 18, 2016

Report 5966099 · MDR key 5966099

Device

Generic name

Stimulator, Photic, Evoked Response

Product problems

  • Thermal Decomposition of Device

Patient

58 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING SPINAL SURGERY, THE NEUROSTIMULATOR REP NOTED CHANGED ON THE MONITOR AND EVALUATED THE ELECTRODE PINS ON THE PATIENT. THE REP NOTED BURNS AT THE ELECTRODE PIN SITES.