InjuryLOF
PEMF - CERVICAL STIM
Received Dec 17, 2025 · Event occurred May 24, 2023
Report 2183449-2025-00039 · MDR key 23835003
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Male
- Bradycardia
- Loss of consciousness
- Bradycardia
- Loss of consciousness
Narrative
Description of Event or Problem
PATIENT REPORTED HE WAS DEVELOPING BRADYCARDIC HEART RHYTHM AND EXPERIENCED LOSS OF CONSCIOUSNESS. PATIENT STATED HE HAS NO HISTORY OF SUCH SYMPTOMS. PATIENT SEEKED TREATMENT FOR BRADYCARDIC HEART RHYTHM AND HAS HAD A 3 VESSEL BYPASS.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE PATIENT RESUMED USE AFTER BEING TREATED FOR CARDIAC SYMPTOMS BY CARDIOLOGIST. IT CANNOT BE DETERMINED IF THE LOSS OF CONSCIOUSNESS WAS DEVICE RELATED. NO ADDITIONAL INFORMATION WAS PROVIDED.