Freedom-8A Receiver Kit Channel A US w/ Receiver FR8A-RCV-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00818225020693), received between Dec 20, 2018 and Feb 24, 2025 — classified as 1 death, 51 injuries.

The most frequently reported specific device problem is “Migration” (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 52 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, SUPPORT RECEIVED A CALL FROM THE ICU DEPARTMENT FOR (B)(6) REQUESTING MRI CLEARANCE ON A PATIENT WHO WAS INCAPACITATED. THE ICU NURSE WAS GOING TO RELAY THE INFORMATION TO THE RADIOLOGIST TO MAKE A DECISION ON PERFORMING AN MRI. AS OF FEBRUARY 13, 2025, SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE PATIENT WITHOUT SUCCESS. CURONIX IS UNABLE TO CONFIRM IF AN MRI WAS PERFORMED, WHAT WAS MEANT BY "INCAPACITATED", OR CURRENT PATIENT STATUS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21454195 ↗
• InjuryDec 11, 2024Circuit Failure; Fracture; Use of Device Problem; Migration; Circuit Failure; Fracture; Use of Device Problem; Migration

  THE PATIENT REPORTED LOSS OF THERAPY AND INCREASED PAIN AFTER A SNOWBOARDING ACCIDENT AND MIGRATION WAS CONFIRMED VIA X-RAY. ATTEMPTS WERE MADE TO CHANGE THE TRANSMITTER SETTINGS WITH NO SUCCESS AND AN EXPLANT PROCEDURE WAS SCHEDULED FOR (B)(6) 2024. DURING THE EXPLANT PROCEDURE, ONE OF THE NEUROSTIMULATORS WAS REMOVED WITHOUT ISSUE. HOWEVER, THE SECOND DEVICE WAS BROKEN OFF AT THE LAMINA AND COULD NOT BE COMPLETELY EXPLANTED. THE PATIENT WAS REFERRED TO A NEUROSURGEON TO PERFORM A MICRO-LAMINOTOMY TO REMOVE THE FRAGMENT OF THE DEVICE THAT REMAINED IMPLANTED. ON (B)(6) 2024, THE REMAINING PORTION OF THE DEVICE WAS EXPLANTED. THE PATIENT IS DOING WELL AND WILL BE IMPLANTED WITH TWO NEW NEUROSTIMULATORS (DATE IS UNKNOWN).

  Patient problems: Pain

  MAUDE report 20907617 ↗
• InjuryDec 3, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED LOSS OF THERAPY. AFTER INCREASING THE TRANSMITTER SETTINGS, THE PATIENT REPORTED LESS PAIN IN THEIR FEET. HOWEVER, THE PATIENT IS REPORTEDLY EXPERIENCING OVERSTIMULATION IN THE MORNING AND EVENINGS WHEN LAYING DOWN ON THEIR BACK AND STRETCHING OUT THEIR LEGS. THE STRETCHING LEADS TO CRAMPING IN THEIR CALVES AND FEET LOCKING UP. THE TRANSMITTER SETTINGS WERE DECREASED AND THE PATIENT WILL FOLLOW-UP WITH THEIR PHYSICIAN ON (B)(6) 2024. THE PATIENT FOLLOWED UP WITH THEIR PHYSICIAN AND THE TRANSMITTER SETTINGS WERE NOT CHANGED. THE PATIENT IS ON A PLACEBO PROGRAM AND DUE TO PSYCHOLOGICAL CONCERNS, THE TRANSMITTER SETTINGS WERE NOT CHANGED. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY AND NO OTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Electric Shock

  MAUDE report 20835097 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED DULL ACHING IN THEIR THORACIC SPINE AREA TWO WEEKS AFTER AN MRI. ALTHOUGH THE PAIN HAS DECREASED OVER TIME, IT HAS NOT GONE AWAY. X-RAYS HAVE NOT BEEN PERFORMED TO CONFIRM DEVICE PLACEMENT AS THE PATIENT HAS BEEN TRAVELING FOR WORK. THE COMMERCIAL TEAM MEMBER NOTED THE DEVICE IS WORKING FOR ITS INTENDED PURPOSE. HOWEVER, THE PATIENT WOULD LIKE ADJUSTMENTS TO IMPROVE THE QUALITY OF THERAPY. ADDITIONAL INFORMATION WAS PROVIDED ON SEPTEMBER 16, 2024. X-RAYS WERE PERFORMED WHICH SHOWED THE DEVICE POSITION WAS UNCHANGED COMPARED TO IMAGES TAKEN IN 2020. HOWEVER, THERE WERE MULTILEVEL DEGENERATIVE CHANGES INVOLVED IN THE THORACIC SPINE. THE PATIENT STATUS REMAINS UNCHANGED.

  Patient problems: Pain

  MAUDE report 20232313 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHOCK AND A HEATING SENSATION THAT TRAVELED FROM THEIR HIPS AND UP THEIR BACK DURING AN MRI. THE MRI WAS ABORTED. IT WAS VERIFIED THAT THE CONDITIONS OF THE MRI WERE SET ACCORDINGLY AND VERIFIED BY THE MRI TECHNICIAN BEFORE THE MRI WAS CONDUCTED. THE PATIENT HAS NOT USED THE DEVICE SINCE (B)(6) 2024, THEY ARE CURRENTLY TRYING TO FIND A NEW PAIN PHYSICIAN, AND THEY HAVE NOT EXPERIENCED ANY ADDITIONAL SHOCK OR HEAT SENSATIONS.

  Patient problems: Burning Sensation; Electric Shock

  MAUDE report 20141910 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A RASH ON THEIR BACK AND WAS SEEN BY THEIR DERMATOLOGIST WHO DETERMINED THE RASH MAY BE A RESULT OF THE NEUROSTIMULATOR. THE PATIENT IS SCHEDULED TO SEE THEIR PAIN PHYSICIAN (B)(6) 2024. HOWEVER, THE PATIENT CURRENTLY HAS NO COMPLAINTS OTHER THAN A MILD RASH.

  Patient problems: Rash

  MAUDE report 19629118 ↗
• InjuryJun 20, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED THEY ARE EXPERIENCING MORE PAIN THAN NORMAL AFTER A RECENT FALL. THE COMMERCIAL TEAM MEMBER MET WITH THE PATIENT ON (B)(6) 2024 AND REPROGRAMMED THEIR DEVICE. ADDITIONALLY, AN X-RAY WAS ADVISED TO CONFIRM DEVICE PLACEMENT. HOWEVER, IMAGING WAS NOT PERFORMED. THE PATIENT NOTICED IMPROVEMENT UPON LEAVING THE OFFICE AND RUNNING THE DEVICE FOR 20 MINUTES AND THEY ARE CURRENTLY NOT EXPERIENCING PAIN.

  Patient problems: Fall; Pain

  MAUDE report 19578708 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHOCKING SENSATIONS ON THE RIGHT TORSO AND DOWN THE THIGH DURING A 3T MRI. THE PATIENT HAS SEVERAL TOTAL JOINT IMPLANTS. FOLLOWING THE MRI THE PATIENT STILL HAD SLIGHT PAIN AND HAD NOT USED THE DEVICE SINCE THE EVENT. THE PATIENT REACHED OUT INQUIRING IF THE DEVICE COULD STILL BE USED AND IF ANY DAMAGE WAS DONE. THE PATIENT WAS INSTRUCTED TO PUT THE DEVICE BACK ON AND BEGAN RECEIVING RELIEF WITHIN 30 MINUTES. THE PATIENT IS NO LONGER EXPERIENCING SLIGHT PAIN AND IS SATISFIED WITH THE PAIN RELIEF THEY ARE CURRENTLY RECEIVING.

  Patient problems: Electric Shock; Pain

  MAUDE report 19114531 ↗
• InjuryApr 9, 2024Off-Label Use; Off-Label Use

  THE PATIENT SUSPECTS THEY MAY BE ALLERGIC TO THE DEVICES AS THE PATIENT FEELS INTENSE ITCHING UNDERNEATH THEIR SKIN AROUND THEIR UPPER BODY. THE SURGEON PRESCRIBED STEROIDS FOR THE ALLERGIC SYMPTOMS AND WANTS TO TRY PROGRAMMING THE DEVICES AT ANOTHER TIME ONCE REACTIONS HAVE SETTLED. THE COMMERCIAL TEAM MEMBER ATTENDED THE PATIENT'S POST OP VISIT AND AT THAT TIME, NO ALLERGY SYMPTOMS WERE REPORTED. REPROGRAMMING WAS SCHEDULED FOR (B)(6) 2024. HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN ISSUE UNRELATED TO THE CURONIX DEVICES. THE PATIENT HAS BEEN RECEIVING KETAMINE INFUSIONS. THE PATIENT WAS DISCHARGED ON (B)(6) 2024, AND REPROGRAMMING HAS BEEN PROVISIONALLY RESCHEDULED FOR (B)(6) 2024.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 19076265 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED UPPER BACK PAIN AND DECREASED THERAPY. X-RAYS CONFIRMED DEVICE MIGRATION. THE DEVICE WAS REPROGRAMMED ALTHOUGH THE PAIN WAS UNCHANGED WITH OR WITHOUT THE STIMULATOR IN USE. THE PATIENT REPORTED THE STIMULATOR IS HELPING, BUT JUST NOT ENOUGH. A CT SCAN IS SCHEDULED HOWEVER AN EXACT DATE WAS NOT PROVIDED.

  Patient problems: Pain

  MAUDE report 18328228 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED UNDERGOING THROUGH AN MRI IN 2022 AND EXPERIENCING SHOCK DURING THE PROCEDURE (PREVIOUSLY REPORTED IN COMPLAINT (B)(4)). ADDITIONALLY, THE PATIENT REPORTED SEVERE BACK PAIN AFTER THE MRI. AN EXPLANT PROCEDURE WAS PERFORMED IN (B)(6) 2022 (SPECIFIC DATE IS UNKNOWN). THE PATIENT EXPERIENCED SHORT TERM MEMORY LOSS WHICH STARTED 3 OR 4 MONTHS AGO (AFTER THE EXPLANT PROCEDURE). THE PATIENT IS ELDERLY AND THE DOCTOR HAS RECOMMENDED THEY SEE A NEUROLOGIST FOR THE MEMORY LOSS.

  Patient problems: Memory Loss/Impairment; Pain

  MAUDE report 18188128 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED NUMBNESS, IMMOBILITY, DISCOMFORT, AND SEVERE SWELLING IN THEIR LEG. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2023 WHICH RESOLVED THE SWELLING. THE PATIENT IS DOING WELL, MOBILITY HAS RETURNED, AND THEY ARE EXPECTED TO BE IMPLANTED WITH A NEW LEAD, HOWEVER, A DATE HAS NOT BEEN SET.

  Patient problems: Discomfort; Numbness; Swelling/ Edema

  MAUDE report 18143771 ↗
• InjuryOct 24, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT REPORTED TENDERNESS AND OCCASIONAL SWELLING AT THE RECEIVER/POCKET SITE. THE DOCTOR DOES NOT THINK THERE IS AN INFECTION. THE PATIENT IS WEARING THE DEVICE AND GETTING RELIEF. HOWEVER, A REVISION PROCEDURE IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Swelling/ Edema

  MAUDE report 17996658 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED REDNESS, SORENESS AND A SMALL OPENING AT THE INCISION. ANTIBIOTICS WERE PRESCRIBED, THE INCISION WAS CLEANED WITH ALCOHOL PADS AND COVERED WITH DERMABOND, AND AN EXPLANT PROCEDURE WAS PLANNED. HOWEVER, THE PROCEDURE WAS CANCELED AS THE PATIENT NO LONGER SHOWED SIGNS OF INFECTION. THE PATIENT IS DOING GOOD, THERE ARE NO SIGNS OF INFECTION AND THEY ARE WEARING THE DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17597563 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED MORE PAIN FOLLOWING A REPROGRAMMING SESSION. THE PATIENT WAS INSTRUCTED NOT TO USE THE DEVICE FOR A WEEK AND THE DEVICE WAS REPROGRAMMED AN ADDITIONAL TIME. AFTER REPROGRAMMING, THE PATIENT IS INCREASING THEIR MEDICATION AND THE DOCTOR WILL GIVE THEM AN INJECTION.

  Patient problems: Pain

  MAUDE report 17515549 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED NOT RECEIVING ANY PAIN RELIEF AND BEING HOSPITALIZED TWO WEEKS AFTER THE PERMANENT IMPLANT PROCEDURE. THE CAUSE FOR HOSPITALIZATION IS UNKNOWN AS THE PATIENT AND THE HOSPITAL COULD NOT PROVIDE A REASON. HOWEVER, THE PATIENT REPORTED FEELING PARALYSIS WHEN THEY REACH OVER THEIR HEAD PRIOR TO THE IMPLANT. ADDITIONALLY, THE PATIENT MENTIONED FEELING PAIN IN THE MORNING AS THEY DO NOT WEAR THE DEVICE AT NIGHT. THE PATIENT WAS INSTRUCTED TO WEAR THE DEVICE 30 MINUTES PRIOR TO GETTING UP. ADDITIONALLY, THE DEVICE WAS REPROGRAMMED AND THE PATIENT'S PAIN LEVELS DROPPED SIGNIFICANTLY AND THE DEVICE IS WORKING WELL.

  Patient problems: Pain

  MAUDE report 17453741 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICAL REPRESENTATIVE REPORTED AN IMPLANT PROCEDURE WAS ABORTED DUE TO A CEREBROSPINAL FLUID (CSF) LEAK. THE PATIENT DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION AND THEY ARE DOING WELL. NO FURTHER ISSUES HAVE BEEN REPORTED AND THE PATIENT IS PLANNING TO RESCHEDULE THE IMPLANT PROCEDURE.

  Patient problems: Perforation

  MAUDE report 16820033 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A HEART ATTACK THE DAY FOLLOWING THE IMPLANT PROCEDURE. THEY WERE TAKEN TO THE HOSPITAL AND WERE IN THE ICU. THE PATIENT WAS NOT USING THE DEVICE WHEN THE HEART ATTACK OCCURRED. THE PATIENT SPENT APPROXIMATELY 6 WEEKS IN THE HOSPITAL AND REHAB. THE PATIENT BEGAN USING THEIR TRANSMITTER ASSEMBLY ON (B)(6) 2023.

  Patient problems: Myocardial Infarction

  MAUDE report 16745269 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A POSSIBLE INFECTION AS WELL AS, BLEEDING AND PAIN. THE POST-OP APPOINTMENT WAS NORMAL AND THE PATIENT IS DOING WELL WITH THERAPY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16663465 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED IRRITATION AT THE WOUND SITE. AN INCISION AND DRAINAGE (IND) PROCEDURE WAS PERFORMED FOR SUSPECTED INFECTION, HOME HEALTH AND ANTIBIOTICS WERE PRESCRIBED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2022 AND THE PATIENT IS DOING WELL.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15982899 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN SCS IMPLANT THE DEVICE WAS NOT ABLE TO BE IMPLANTED AS THE DOCTOR WAS UNABLE TO ADVANCE THE ELECTRODE ARRAY MIDLINE. THE ELECTRODE ARRAY KEPT ADVANCING VENTRAL. THE PATIENT WAS UNDER ANESTHESIA FOR 30-45 MINUTES AND THE PATIENT RECOVERED FROM ANESTHESIA WITHOUT ANY ISSUE. THERE WILL BE ANOTHER ATTEMPT TO IMPLANT WHEN THE PATIENT DECIDES TO RESCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621247 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED FROM THE MOMENT THE MRI STARTED THEY FELT A SHOCK DOWN THE CENTER OF THEIR BODY STARTING WITH THEIR FEET, MOVING UP THE BODY. THE MRI WAS ABORTED. THE PATIENT REPORTED THEY HAVE HEADACHES AND PAIN DOWN THE LEFT SIDE OF THEIR BODY POST MRI AND HOPES THIS WILL GO AWAY. THE IMPLANTING CLINICIAN IS CURRENTLY OUT OF THE OFFICE. HOWEVER, THE PATIENT WILL FOLLOW-UP THE WEEK OF (B)(6), 2022 WHEN THE IMPLANTING CLINICIAN RETURNS.

  Patient problems: Electric Shock

  MAUDE report 15594900 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EROSION. ALTHOUGH AN INFECTION WAS NOT CONFIRMED, ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2022. DURING THE EXPLANT PROCEDURE IT WAS NOTICED THAT THE LEAD WAS FRACTURED. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Erosion

  MAUDE report 15429547 ↗
• InjuryApr 20, 2022Material Erosion

  THE PATIENT REPORTED AN INFECTION AND EROSION OF BOTH STIMULATORS. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2022. THE PATIENT IS DOING WELL AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Skin Infection

  MAUDE report 14164035 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A BUMP/KNOT NEAR THE LOWER INCISION THAT IS PAINFUL. THE IMPLANTING CLINICIAN REPORTED THE INCISION IS NOT INFECTED (NO REDNESS, NOT WARM TO THE TOUCH AND NOT SWOLLEN) AND IT IS NOT ERODING FROM THE SKIN. THERE WILL BE A FOLLOW UP APPOINTMENT IN 4-6 WEEKS TO ENSURE THE POCKET CONTINUES TO HEAL WITHOUT INCIDENT. NO REVISION/EXPLANT IS SCHEDULED AT THIS TIME.

  Patient problems: Implant Pain

  MAUDE report 13720289 ↗