PEMF - SPINAL STIM
Received Dec 17, 2025 · Event occurred Jul 22, 2024
Report 2183449-2025-00041 · MDR key 23835154
Device
Generic name
Bone Growth Stimulator
Manufacturer
Orthofix, LlcModel number
655212-0001Catalog number
5212
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR · Female
- Loss of consciousness
- Loss of consciousness
Narrative
Additional Manufacturer Narrative
PATIENT STATED HER PHYSICIAN DOES NOT SUSPECT SS BUT SUSPECTS HER HEART TO HAVE CONTRIBUTED TO THE EVENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO CAUSE ESTABLISHED. PATIENT CONTINUED TO TREAT USING THE DEVICE WITH CAUTION AS DIRECTED BY THE PRESCRIBING PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE DEVICE IS NOT AVAILABLE FOR FURTHER INVESTIGATION.
Description of Event or Problem
PATIENT REPORTED FEELING NAUSEOUS AND THEN LOST CONSCIOUSNESS WHILE FINISHING TREATMENT. PATIENT WENT TO URGENT CARE AND WAS TREATED FOR HEART SYMPTOMS.