CERVICAL STIM

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR INVESTIGATION. CONFIRMED DEVICE MET DESIGN SPECIFICATION AND WORKED AS INTENDED. DHR HAS BEEN REVIEWED DURING INVESTIGATION AND ALL UNITS FROM THE WORK ORDER PASSED FINAL INSPECTION.

Description of Event or Problem

PATIENT REPORTED FALLING ASLEEP WITH THE DEVICE ON AND THE COLLAR SLIPPED UP AROUND THE JAW AREA FOR ABOUT ONE HOUR. UPON WAKING THE PATIENT REPORTED HEARING GOING OUT AND WATER/FLUID CAME OUT OF THE EAR. THE PATIENT WAS SEEN BY THE PRESCRIBING DOCTOR AND WAS PRESCRIBED MEDICATION. PATIENT DISCONTINUED USE OF THE DEVICE.