SPINAL STIM 5212Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 18257200105670), received between Nov 22, 2017 and Jun 26, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026No Apparent Adverse Event

  MEWATCH REPORT RECEIVED STATING THE PATIENT REPORTED A REACTION THAT IRRITATED THEIR WHOLE CHEST. THE ISSUE BEGAN THEY WOULD SAY AROUND AUGUST.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25641511 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SCABBING BURN MARKS AND CALLUS MARKS HAVE DEVELOPED ON THE LOWER BACK AND REPORTED THE AREA BEING TENDER AFTER TREATING. PATIENT DISCONTINUED USE OF THE DEVICE.

  Patient problems: Burn(s)

  MAUDE report 25035459 ↗
• InjuryApr 1, 2026Insufficient Device Problem Information

  IT WAS REPRTED THE PATIENT WAS EXPERIENCING PAIN IN HIS HIPS, LEGS, AND FEET AFTER STARTING TREATMENT ON (B)(6) 25. AFTER A FOLLOW UP CALL 3/26/2026 THE PATIENT REPORTED THE DEVICE CAUSED A NERVE TO FEEL HOT AND PAINFUL. THE PATIENT IS WORKING WITH HIS DOCTOR AND SEEKING ADDITIONAL TREATMENT.

  Patient problems: Pain

  MAUDE report 24753593 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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.

  Patient problems: Dysuria; Unspecified Kidney or Urinary Problem

  MAUDE report 23835261 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED FEELING THE DEVICE AND BODY WAS GETTING WARM AFTER AN HOUR OF TREATMENT. PATIENT REPORTED NOTICING IT TWO WEEKS AFTER INITIAL TREATMENTS STARTED. THE SENSATION WENT AWAY AFTER STOPPING TREATMENT AND ALSO MENTIONED REFLUX WITH SIMILAR ONSET OF TREATING WITH THE DEVICE.

  Patient problems: Skin Burning Sensation

  MAUDE report 23743339 ↗
• InjuryOct 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT SENT AN EMAIL REPORTING SHE BELIEVES THE DEVICE CAUSED BURNS ON HER BACK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 23350620 ↗
• InjurySep 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REPORTED HAVING A REACTION TO THE UNIT CAUSING BURNS ON THE RIGHT LEG. PATEINT STATES IT STARTED THE FIRST DAY OF TREATMENT BUT THE UNIT DID NOT GET HOT, HE JUST HAD A REACTION. PATIENT DISCONTINUED USE. NO FURTHER DETAILS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 23029128 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED THE PATIENT WAS SHOCKED DURING TREATMENT BY THE DEVICE. IT WAS REPORTED THERE WAS A RED BURN MARK WHERE THE DEVICE SITS.

  Patient problems: Burn(s)

  MAUDE report 21987456 ↗
• InjuryMar 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT CALLED AND REPORTED FEELING HOT SPOTS ALL OVER BODY (SIDE, STOMACH, THIGH) STARTING A WEEK AGO FROM TODAY. HIPS AND BACK WERE FEELING UNSTABLE AND UNABLE TO WALK. HIPS FEEL LIKE THEY ARE GOING TO GIVE OUT. PATIENT DISCONTINUED USING THE DEVICE. SHE WAS ADVISED TO CONTACT HER PHYSICIAN AND SHE STATED SHE HAS NOT CONTACTED PROVIDER.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 21680297 ↗
• InjuryMar 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED CUSTOMER SERVICE AND REPORTED THAT THE 655212-0001 SPINAL STIM DEVICE GAVE HER A BURN. PATIENT REPORTED THAT SHE WAS WEARING A METAL WIRE IN HER BRA AND THE DEVICE BURNED HER WHERE THE WIRE SITS. THREE ATTEMPTS VIA PHONE CALL WERE MADE TO RETRIEVE THE DEVICE FOR INVESTIGATION BUT WE WERE UNABLE TO REACH THE PATIENT.

  Patient problems: Burning Sensation

  MAUDE report 21655055 ↗
• InjuryNov 22, 2017Inappropriate/Inadequate Shock/Stimulation; Device Operates Differently Than Expected

  INFORMATION PROVIDED STATES THAT DURING INITIAL TREATMENT WITH BONE GROWTH STIMULATOR PATIENT WAS PHYSICALLY SHOCKED IN HER HIP AREA WHERE SHE HAS A IMPLANTED BLADDER STIMULATOR, MEDTRONIC MODEL 3037. PATIENT HAD FOLLOW UP WITH UROLOGIST AND WAS TOLD THAT HER BLADDER STIMULATOR HAD BEEN DAMAGED BY THE BONE GROWTH STIMULATOR. PATIENT MAY REQUIRE REVISION SURGERY TO REPAIR/REPLACE HER BLADDER STIMULATOR.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 7053282 ↗