PEMF - SPINAL STIM
Received Dec 17, 2025 · Event occurred Aug 6, 2024
Report 2183449-2025-00043 · MDR key 23835261
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
68 YR · Male
- Dysuria
- Unspecified Kidney or Urinary Problem
- Dysuria
- Unspecified Kidney or Urinary Problem
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, THERE IS NO CAUSE ESTABLISHED. PATIENT REPORTED PHYSICIANS HE CONSULTED WERE UNSURE WHAT WAS CONTRIBUTING TO THE SYMPTOMS EXPERIENCED. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE DEVICE IS NOT AVAILABLE FOR FURTHER INVESTIGATION.
Description of Event or Problem
PATIENT REPORTED THAT BLADDER FUNCTION WAS LOST DURING DEVICE TREATMENT PLAN AFTER 4 TIMES OF USE. PATIENT HAD A CATHETER INSERTED AND AFTER 7 DAYS, IT WAS REMOVED BUT PATIENT COULD NOT URINATE WITHOUT CATHETER. ANOTHER CATHETER WAS INSERTED FOR 10 DAYS AND ONCE REMOVED, PATIENT COULD URINATE BUT HAD NO BLADDER CONTROL. PATIENT DISCONTINUED USE OF DEVICE AS ADVISED MY PHYSICIAN.