Freedom-8A Spare Kit Channel B US w/Receiver FR8A-SPR-B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00818225020648), received between Dec 12, 2018 and Jul 7, 2026 — classified as 1 death, 27 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• DeathJul 7, 2026Adverse Event Without Identified Device or Use Problem

  THE COMMERCIAL TEAM MEMBER WAS NOTIFIED THE PATIENT PASSED AWAY ON (B)(6) 2026. THE CAUSE OF DEATH WAS DUE TO LYMPHOMA AND WAS UNRELATED TO THE CURONIX DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25737140 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED TWO SHOCKING SENSATIONS DURING AN MRI OF THEIR LUMBAR SPINE. AFTER THE FIRST SHOCKING SENSATION AT THE BEGINNING OF THE PROCEDURE, THE MRI TECHNICIAN PAUSED THE PROCEDURE FOR ABOUT 15 MINUTES AND CONTINUED THE MRI. AFTER CONTINUING WITH THE MRI, THE PATIENT RECEIVED A SECOND SHOCK AND THE PROCEDURE WAS ABORTED. AS OF (B)(6) 2026, THE PATIENT HAS NOT FELT ANY OTHER SENSATIONS FROM THE DEVICE. THE PATIENT IS CURRENTLY NOT WEARING THE DEVICE AND WANTS THE DEVICE EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24025469 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTEDLY HOSPITALIZED FROM (B)(6) 2025 THROUGH (B)(6) 2025 WITH BAD STAPH INFECTION. IV ANTIBIOTICS WERE PRESCRIBED FOR THE INFECTION. THE INFECTION WAS THE RESULT OF A PROCEDURE TO SWAP OUT THE BATTERY ON THEIR NON-CURONIX SCS SYSTEM WHICH WAS PERFORMED ON (B)(6) 2025. THE PATIENT IS WAITING FOR AN MRI ON (B)(6) 2025, AND FOR NEW LABS TO BE DRAWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection

  MAUDE report 23573030 ↗
• InjuryAug 23, 2024Expulsion; Expulsion

  DURING THE PATIENTS WOUND CHECK APPOINTMENT, ONE OF THEIR NEUROSTIMULATORS WAS ERODING. THE CLINICIAN PULLED THE NEUROSTIMULATOR OUT. THE EXACT DATE IS UNKNOWN AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Erosion

  MAUDE report 20047031 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A FURUNCLE THAT WAS ADJACENT TO THE LOWER LEVEL OF WHERE THE RECEIVER WAS IMPLANTED WHICH CAUSED EROSION. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE THE FURUNCLE WAS LANCED AND ANTIBIOTICS WERE PRESCRIBED. WHILE LANCING THE FURUNCLE, THE STIMULATOR WAS CUT AND AS A RESULT, THE PATIENT EXPERIENCED LOSS OF THERAPY. AT A LATER APPOINTMENT, THE IMPLANTING CLINICIAN MET WITH THE PATIENT, OPENED THE LOWER PART OF THE POCKET AND FOUND NO INFECTION, GENTLY CLOSED THE INCISION, AND PRESCRIBED ADDITIONAL ANTIBIOTICS. ATTEMPTS TO REPROGRAM THE TRANSMITTER ASSEMBLY WERE MADE. HOWEVER, THEY WERE UNSUCCESSFUL. ADDITIONALLY, AN EXPLANT PROCEDURE IS PLANNED. A DATE IS NOT YET SCHEDULED.

  Patient problems: Erosion

  MAUDE report 18341109 ↗
• InjuryOct 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT REPORTED MIGRATION AND NEW PAIN IN THEIR LEFT HIP. THE PATIENT HAS NOT WORN THE DEVICE FOR OVER A YEAR. THE PATIENT WILL FOLLOW UP WITH THEIR PHYSICIAN.

  Patient problems: Pain

  MAUDE report 17953917 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED LOSS OF THERAPY AND A BROKEN IMPLANT. THE PATIENT HAS NOT USED THE THERAPY SINCE 2020. HOWEVER, MULTIPLE REPROGRAMMING ATTEMPTS WERE MADE WITHOUT SUCCESS. THE REPORTED ISSUE OF BROKEN IMPLANT HAS NOT BEEN CONFIRMED AS X-RAYS HAVE NOT BEEN OBTAINED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17757722 ↗
• InjurySep 5, 2023Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED SHOCK DURING AN MRI SCAN. THE MRI WAS ABORTED. THE PATIENT'S DEVICE WAS REPROGRAMMED AND IS REDUCING THE PATIENT'S PAIN BY 50%. ADDITIONALLY, THE PATIENT IS NOT EXPERIENCING ANY ADVERSE EVENTS FOLLOWING THE MRI.

  Patient problems: Electric Shock

  MAUDE report 17687792 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED WOUND HEALING ISSUES. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2023. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Impaired Healing

  MAUDE report 17550837 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION, SWELLING, FEVERS AND INFLAMMATION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 17302988 ↗
• InjuryFeb 14, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SEVERE PAIN IN THEIR RIGHT HIP POST IMPLANT. MIGRATION WAS CONFIRMED VIA CT SCAN. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2023 AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Implant Pain

  MAUDE report 16374987 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT REPORTED EXCRUCIATING PAIN AND A DIFFICULT PROCEDURE. THE CLINICAL REPRESENTATIVE AND CUSTOMER SUPPORT CONDUCTED MULTIPLE ATTEMPTS TO CONTACT THE PATIENT. HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL.

  Patient problems: Pain

  MAUDE report 16280221 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A VERY STRONG TINGLING FEELING IN THEIR FEET DURING AN MRI PROCEDURE. THE PATIENT IS EXPERIENCING RELIEF AND THE DEVICE IS WORKING.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 16017290 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED IRRITATION AT ONE OF THE INCISION LOCATIONS. THE IRRITATION WAS DESCRIBED AS A "PIMPLE" AND WHEN IT "BURST," THE END OF THE ONE OF THE LEADS WAS EXPOSED. A REVISION PROCEDURE WAS ATTEMPTED ON (B)(6) 2022 HOWEVER THE PHYSICIAN WAS UNABLE TO GET THE LEADS TO THE NECESSARY LOCATION AND THE STIMULATOR WAS EXPLANTED. THE PATIENT IS DOING WELL AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Erosion; Skin Inflammation/ Irritation

  MAUDE report 15971211 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A LOSS OF THERAPY, CRAMPS, AND SPASMS. MULTIPLE REPROGRAMMING ATTEMPTS WERE MADE. THE PATIENT STOPPED TAKING PRESCRIBED NEUROPATHY MEDICATION. THERE ARE NO PLANS FOR AND EXPLANT/REVISION PROCEDURE AT THIS TIME. HOWEVER, THE PHYSICIAN WILL PROCEED WITH COMPLEMENTARY THERAPIES AND DISCUSS RE-STARTING NEUROPATHY MEDICATION THAT PATIENT STOPPED TAKING.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 15673741 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SPASMS, NUMBNESS, TINGLING, AND PAIN. THE DEVICE WAS REPROGRAMMED AND REPLACEMENT ANTENNAS WERE PROVIDED TO THE PATIENT. THE CLINICAL REPRESENTATIVE HAS REACHED OUT TO THE PATIENT FOR ADDITIONAL REPROGRAMMING. HOWEVER, THEY HAVE NOT BEEN ABLE TO MAKE CONTACT WITH THE PATIENT. THERE ARE NO PLANS FOR AN EXPLANT OR REVISION AT THIS TIME.

  Patient problems: Numbness; Pain

  MAUDE report 15246785 ↗
• InjuryJul 21, 2022Break

  DURING THE PERMANENT IMPLANT PROCEDURE, THE IMPLANTING CLINICIAN INADVERTENTLY SEVERED THE LEAD AND BROKEN/FRACTURED PIECES OF THE STIMULATOR WERE LEFT IMPLANTED. THE PHYSICIAN SEEMED TO HAVE MADE AN EDUCATION DECISION BASED ON THEIR KNOWLEDGE OF THE AREA/PATIENT TO LEAVE THE FRACTURED PORTION OF THE LEAD BEHIND. FLUORO IMAGES WERE TAKEN TO DETERMINE THE NEXT STEPS AND A FOLLOW-UP APPOINTMENT IS SCHEDULED FOR (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 15077961 ↗
• InjuryJul 12, 2022Patient Device Interaction Problem

  THE PATIENT REPORTED PAIN AT THE RECEIVER POCKET WHEN THEY PRESS ON IT AND THEY CAN SEE THE WIRE UNDER THE SKIN. THE PATIENT HAS NOT BEEN WEARING THE WEARABLE ANTENNA ASSEMBLY. ADDITIONALLY, THEY HAVE NOT BEEN ABLE TO GET AN X-RAY TO CONFIRM STIMULATOR LOCATION AS THEY ARE DEALING WITH OTHER UNRELATED HEALTH ISSUES.

  Patient problems: Pain

  MAUDE report 14986611 ↗
• InjuryFeb 11, 2022Output Problem

  ON (B)(6) 2021, THE PATIENT REPORTED A LOSS OF THERAPY. THE STIMWAVE CLINICAL REPRESENTATIVE ATTEMPTED REPROGRAMMING THE WAA TO RE-ESTABLISH PAIN RELIEF. WHEN THE CLINICAL REPRESENTATIVE INCREASED THE AMPLITUDE OF THE PROGRAMMING PARAMETERS, THE PATIENT REPORTED FEELING A SHOCKING SENSATION. THE SHOCKING SENSATION EXPERIENCED BY THE PATIENT WAS REPORTED BY THE CLINICAL REPRESENTATIVE TO STIMWAVE QUALITY ON (B)(6) 2022. THE PATIENT IS CURRENTLY RECEIVING MINIMAL RELIEF.

  Patient problems: Electric Shock

  MAUDE report 13514298 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT HAD FLUID COMING FROM SPINAL CORD IMPLANT INCISION SITE. AS A RESULT, THE DOCTOR PRESCRIBED ANOTHER WEEK OF ANTIBIOTICS.

  Patient problems: Fluid Discharge

  MAUDE report 12368390 ↗
• InjuryJul 13, 2021Material Erosion

  IMPLANTING CLINICIAN'S OFFICE REPORTS EROSION. THE STIMULATOR WAS REMOVED ON (B)(6) 2021. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Skin Erosion

  MAUDE report 12163909 ↗
• InjuryJul 2, 2021Migration or Expulsion of Device

  POST- OPERATIVELY, PATIENT RETURNED TO PHYSICIAN REPORTING AN INFECTION AND SORENESS AND DISCOMFORT AT THE INCISION SITE. THE IMPLANTING PHYSICIAN ATTEMPTED TO DRAIN THE INCISION AREA, AND NOTES THE LEADS HAD MIGRATED.

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

  MAUDE report 12108285 ↗
• InjuryJun 5, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT IS SUFFERING FROM AN INFECTION WHICH IS BEING TREATED WITH ANTIBIOTICS. THE IMPLANTING CLINICIAN STATED REVISION/EXPLANT NOT NEEDED, AND NO FURTHER ISSUES HAVE BEEN REPORTED.

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

  MAUDE report 11943976 ↗
• InjuryApr 9, 2021Use of Device Problem; Patient-Device Incompatibility

  PATIENT STATED THAT THEIR INCISIONS WERE SWOLLEN AND EXTREMELY SORE, WHICH PREVENTED THEM FROM BEING ABLE TO PROPERLY USE THE SYSTEM. ON (B)(6) 2021, THE PATIENT MET WITH THE IMPLANTING CLINICIAN, WHO EXAMINED THE INCISIONS AND FOUND NO SIGNS OF INFECTION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11642489 ↗
• InjurySep 28, 2020Break; Break

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT OF FRACTURED STIMULATOR REPORTED TO STIMWAVE'S COMPLAINT SYSTEM ON (B)(6) 2020, BY CLINICAL REPRESENTATIVE (CR), IN THE UNITED STATES. STIMWAVE BECAME AWARE OF THE ISSUE ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10597408 ↗