Freedom Spinal Cord Stimulator SystemRecalls & reported problems across all models

We found 4 models of Freedom Spinal Cord Stimulator System by Stimwave Technologies Incorporated in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2018 and Dec 22, 2025 — classified as 2 deaths, 23 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Freedom Spinal Cord Stimulator System problems

Freedom Spinal Cord Stimulator System models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Freedom Spinal Cord Stimulator System FR8A-RCV-A0

  Stimulator, Spinal-Cord, Implanted (Pain Relief)
  2 deaths22 reports
• Freedom Spinal Cord Stimulator System FR8A-RCV-B0
  1 report
• Freedom Spinal Cord Stimulator System FR8A-TRL-A0

  Stimulator, Spinal-Cord, Implanted (Pain Relief)
  1 report
• Freedom Spinal Cord Stimulator System FR8A-TRL-B0

  Stimulator, Spinal-Cord, Implanted (Pain Relief)
  1 report

Recent Freedom Spinal Cord Stimulator System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A BURNING SENSATION DURING A MRI AND THE MRI PROCEDURE WAS ABORTED. THE PATIENT HAS NOT EXPERIENCED ADDITIONAL BURNING SENSATIONS AND HAS CONTINUED USING THERAPY. HOWEVER, THEY REPORTED NO PAIN RELIEF AFTER THE MRI ALONG WITH MUSCLE TENSIONS IN THEIR LEGS WHEN USING THE DEVICE. THE MUSCLE TENSION WAS TREATED WITH KINESIO TAPE AND THE PATIENT SAW A NEUROLOGIST WHO PRESCRIBED MEDICATION. AS OF (B)(6) 2025, THE PAIN IS SLIGHTLY BETTER WITH THE MEDICATION AND AN APPOINTMENT IS SCHEDULED FOR (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Burning Sensation

  MAUDE report 23873286 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED INVOLUNTARY SHAKING IN THEIR LEGS WHEN LAYING DOWN OR SITTING DOWN WHILE USING THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025. THE PATIENT HAS NOT BEEN USING THE DEVICE FOR OVER A YEAR AS THEY FELT THEIR PAIN HAD MOSTLY RESOLVED. ADDITIONALLY, THE PATIENT CLARIFIED THEY EXPERIENCE THE INVOLUNTARY SHAKING AFTER THEY DO PHYSICAL THERAPY OR HAVE A BUSY DAY AND IT HAS NEVER BEEN RELATED TO WEARING THE DEVICE.

  Patient problems: Shaking/Tremors

  MAUDE report 21635825 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A SHOCK GOING DOWN BOTH OF THEIR LEGS AT THE START OF THEIR MRI. THE MRI WAS IMMEDIATELY ABORTED. THE PATIENT IS FINE AND FEELS NO SIDE EFFECTS AFTER THE MRI. THEY HAVE NOT USED THE DEVICE IN OVER SIX MONTHS AND IT IS UNKNOWN IF AN EXPLANT/REVISION PROCEDURE WILL BE PERFORMED.

  Patient problems: Electric Shock

  MAUDE report 15583398 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE CLINICAL REPRESENTATIVE WAS MADE AWARE THAT THE PATIENT HAD AN INFECTION AND THAT AN EXPLANT PROCEDURE WAS PERFORMED ON DECEMBER 18, 2020.

  Patient problems: Post Operative Wound Infection; Skin Inflammation/ Irritation

  MAUDE report 11376685 ↗
• InjuryAug 19, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM A DEVICE EROSION THROUGH THE SKIN REPORTED TO STIMWAVE ON JULY 10, 2019, BY TERRITORY MANAGER.

  Patient problems: Erosion

  MAUDE report 10424448 ↗
• InjuryAug 19, 2020Fracture; Fracture

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS SURROUNDING A COMPLAINT RESULTING FROM AN APPARENT STIMULATOR FRACTURE AT THE MARKER BAND WITH CLINICIAN AND CLINICAL SPECIALIST REPORTED TO STIMWAVE ON (B)(6) 2017. THE STIMULATOR WAS LEFT IN PLACE AT THE PATIENT'S REQUEST. THE STIMULATOR WILL BE EXPLANTED DURING THE PERMANENT PROCEDURE. THIS EVENT DID NOT RESULT IN ANY INJURY TO THE PATIENT AND THEREFORE THE CLINICIAN AND SPECIALIST FILED THE OFFICIAL COMPLAINT LATER THAN THE DAY OF THE INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10424437 ↗
• InjuryAug 19, 2020Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS SURROUNDING A COMPLAINT RESULTING FROM AN EXPLANT PROCEDURE WITH CLINICIAN AND THERAPY SPECIALIST ON (B)(6) 2017. THE STIMULATOR EXPLANT WAS SUCCESSFULLY COMPLETED, HOWEVER, THE DEVICE WAS LITERALLY "PULLED" APART DURING THE EXPLANT. HOWEVER, THIS EVENT DID NOT RESULT IN ANY INJURY TO THE PATIENT AND THEREFORE THE CLINICIAN AND SPECIALIST FILED THE OFFICIAL COMPLAINT IN THE SAME WEEK, BUT NOT ON THE DAY OF THE INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque; Erosion

  MAUDE report 10424436 ↗
• InjuryNov 21, 2019Migration; Migration

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM A DEVICE MIGRATION REPORTED TO STIMWAVE ON APRIL 4, 2017.

  Patient problems: No Code Available

  MAUDE report 9356094 ↗
• DeathNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM A PATIENT DEATH, UNRELATED TO THE DEVICE, REPORTED TO STIMWAVE ON OCTOBER 25, 2019.

  Patient problems: Death

  MAUDE report 9355122 ↗
• DeathNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM A PATIENT DEATH, UNRELATED TO THE DEVICE, REPORTED TO STIMWAVE ON (B)(6) 2019.

  Patient problems: Death

  MAUDE report 9341613 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM AN INCISION SITE NOT HEALING AND SUSPECTED INFECTION REPORTED TO STIMWAVE ON SEPTEMBER 23, 2019, BY TERRITORY MANAGER.

  Patient problems: Unspecified Infection

  MAUDE report 9213510 ↗
• InjuryOct 15, 2019Expulsion; Expulsion

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM A SKIN IRRITATION AND DEVICE EROSION REPORTED TO STIMWAVE ON (B)(6) 2019. THE CLINICAL SPECIALIST WAS MADE AWARE ON (B)(6) 2019, BY THE IMPLANTING CLINICIAN.

  Patient problems: Skin Erosion

  MAUDE report 9193156 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS FROM A MEDWATCH REPORT (MW5087567) SUBMITTED BY A PATIENT. ON JULY 8, 2019, STIMWAVE BECAME AWARE OF THE EVENT UPON RECEIPT OF THE REPORT, WHICH WAS DATED (B)(6) 2019, BY THE FOOD AND DRUG ADMINISTRATION (FDA). THE EVENT DESCRIPTION DETAILED IN THE MEDWATCH REPORT IS AS FOLLOWS: PATIENT REPORTED THAT HE CONTACTED STIMWAVE TECHNOLOGIES INCORPORATED TO LOCATE A PHYSICIAN THAT WOULD IMPLANT THE FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM. HE WAS PROVIDED A SURGEON IN (B)(6) HE STATED THAT THE SURGEON INFORMED HIM THAT HE WOULD BE ABLE TO IMPLANT THE PERMANENT SYSTEM, BUT HE DOES NOT IMPLANT THE TRIAL IMPLANT. THE SURGEON PROVIDED HIM A PAIN SPECIALIST THAT WOULD IMPLANT THE TRIAL AND TOLD HIM TO RETURN ONCE THE TRIAL WAS OVER. ON (B)(6) THE PAIN SPECIALIST IMPLANTED THE TRIAL SYSTEM. THE PT STATED THAT ON THE WAY HOME HE BEGAN TO BLEED AT THE INCISION SITE. HE WENT BACK TO THE IMPLANTING CLINICIANS OFFICE AND THE BANDAGE WAS REMOVED AND THE DR APPLIED PRESSURE TO THE WOUND FOR 20 MINS. THE DOCTOR TOLD HIM THAT THE REASON HE HAD BLEEDING WAS DUE TO A RASH HE HAD PREVIOUSLY. (THE PATIENT NOTES THAT HE INFORMED THE DOCTOR THAT HE WAS SCHEDULE

  Patient problems: Infection, Indirect; Skin Erosion

  MAUDE report 8867134 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS FROM A MEDWATCH REPORT (MW5076893) SUBMITTED BY A HEALTH CARE PROFESSIONAL ON APRIL 17, 2018. ON MAY 8, 2019, STIMWAVE BECAME AWARE OF THE EVENT UPON RECEIPT OF THE REPORT, WHICH WAS DATED APRIL 17, 2018, BY THE FOOD AND DRUG ADMINISTRATION (FDA). THE FOLLOWING EVENT DESCRIPTION WAS PROVIDED IN THE MEDWATCH REPORT: STIMWAVE IMPLANTS MOVEMENT FROM ITS ORIGIN SITE. ON (B)(6) 2017, THE PATIENT UNDERWENT A SPINAL SURGERY FOR PLACEMENT OF STIMWAVE SYSTEM ENTERED AT T12/L1 AND T11/T12 LEVELS. THIS PROCEDURE WAS PERFORMED AS A TREATMENT FOR THE PATIENT'S CHRONIC BACK PAIN. PER THE SURGEON, ON (B)(6) DURING A POST-OPERATIVE CHECK TO ASSESS FUNCTION, THE IMPLANT WAS NOTED ON TO HAVE MOVED CEPHALAD - ONE OF THE LEADS. AS THE LEAD HAD MOVED SUCH THAT IT WOULD POSSIBLY REQUIRE A LAMINECTOMY TO REMOVE IT. ON (B)(6) 2017, IT WAS NOTED TO HAVE MOVED FURTHER CEPHALAD. THE SURGEON STATED THAT SHE CONTACTED THE MANUFACTURER AFTER THIS OCCURRENCE. SHE WAS TOLD THAT THEY KNEW ABOUT THIS ISSUE BUT DID NOT COMMUNICATE TO HER IN ADVANCE. PER THE SURGEON, SO FAR, 3-4 DEVICES HAVE BEEN IMPLANTED AND 2 SHOWED THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8689511 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON FEBRUARY 25, 2019, THE PATIENT MADE FIELD TRAINER AWARE THAT HE HAD HIS STIMULATOR EXPLANTED ON (B)(6) 2019. THE PATIENT DID NOT REPORT ANY INFECTIONS OR OTHER ADVERSE EVENTS WITH THE DEVICE. IMMEDIATELY FOLLOWING NOTIFICATION, STIMWAVE QUALITY REVIEWED THE EVENTS LEADING UP TO AWARENESS OF THE ISSUE. THE FIELD TRAINER REPORTED THAT SHE WAS NOT PRESENT FOR THE IMPLANTATION PROCEDURE, AS SHE HAD RECENTLY ACQUIRED THIS PATIENT FOR FOLLOW-UP, BUT HAD REVIEWED THE PATIENT'S TREATMENT HISTORY WITH THE IMPLANTING CLINICIAN. THE PATIENT WAS IMPLANTED WITH THE FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM ON (B)(6) 2018, IN WHICH ONE (1) FREEDOM-8A RECEIVER STIMULATOR (FR8A-RCV-A0) AND ONE (1) FREEDOM-8A SPARE LEAD (FR8A-SPR-B0) WAS IMPLANTED IN THE PATIENT'S EPIDURAL SPACE AT T8/T9 TO TREAT THE PATIENT'S PERIPHERAL NEUROPATHY. BOTH DEVICES WERE SECURED USING THE SANDSHARK INJECTABLE ANCHOR (SIA) SYSTEM (SHRK-ALL-1K). THERE WERE NO COMPLICATIONS EXPERIENCED DURING THE PROCEDURE AND THE PATIENT WAS SENT HOME. THE CLINICIAN IMPLANTED THE STIMULATOR AND REPORTED NO COMPLICATIONS OR ISSUES WITH PLACEMENT OR PROGRAMMING. AT FOLLOW UP APPOINTMENTS ON (B)(6) 2018, (B)(6) 2018, AND (B)(6) 2018, T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446099 ↗