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

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00818225020679), received between Nov 27, 2018 and Sep 7, 2023 — classified as 18 injuries, 1 malfunction.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A REACTION TO THE ADHESIVE ALONG WITH TENDERNESS AND DISCHARGE FROM INCISIONS. INFECTION WAS NOT CONFIRMED. HOWEVER, ANTIBIOTICS WERE PRESCRIBED, THE IRRITATION IS NOW CLEAR AND THE PATIENT IS DOING WELL.

  Patient problems: Local Reaction; Purulent Discharge

  MAUDE report 17702591 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED BACK SPAMS DURING THE TRIAL PERIOD. PRIOR TO THE PROCEDURE, THE PATIENT WOULD PERIODICALLY GET BACK SPASMS. THE SPASMS CONTINUED DURING THE TRIAL PERIOD WHETHER THE DEVICE WAS ON OR OFF. THE SPASMS WENT AWAY A DAY OR TWO AFTER THE TRIAL WAS REMOVED AND THE PATIENT WANTS TO MOVE FORWARD WITH PERMANENT IMPLANT PROCEDURE IN A COUPLE MONTHS.

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

  MAUDE report 17701916 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN EXPIRED FREEDOM SCS NEUROSTIMULATOR TRIAL LEAD WAS IMPLANTED. THE PRODUCT WAS SHIPPED TO THE CLINICAL REPRESENTATIVE ON JUNE 18, 2021, EXPIRED ON MARCH 01, 2023 AND WAS IMPLANTED ON (B)(6) 2023. THE LEAD PULL WAS PERFORMED AS EXPECTED ON (B)(6) 2023. THE PATIENT HAD A SUCCESSFUL TRIAL WITH NO ADVERSE EVENTS REPORTED, AND WILL BE MOVING FORWARD WITH A PERMANENT IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709729 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICAL REPRESENTATIVE REPORTED A TRIAL PROCEDURE WAS ABORTED AS THE IMPLANTING CLINICIAN PUNCTURED INTO INTRATHECAL SPACE DURING FIRST ATTEMPT WITH EXCESS BLOOD RETURN. THE CLINICIAN ATTEMPTED TO IMPLANT A LEVEL ABOVE. HOWEVER, THE PATIENT FELT OVERSTIMULATED WITH TESTING AND THE CLINICIAN ABORTED THE CASE. THE PATIENT WAS SENT FOR MRI IMMEDIATELY AFTER THE PROCEDURE WAS ABORTED. THE PATIENT IS CURRENTLY DOING WELL AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Device Overstimulation of Tissue; Perforation

  MAUDE report 15898851 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED ON FEBRUARY 8, 2021, FOR A PATIENT THAT WAS SENT TO THE HOSPITAL AFTER COMPLICATIONS WITH ADMINISTERED CONSCIOUS SEDATION AND SUBSEQUENTLY PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 11457019 ↗
• InjuryMar 7, 2021Adverse Event Without Identified Device or Use Problem

  STIMULATOR HAD PERFORATED THE SKIN ON THE LOWER LEG.

  Patient problems: Erosion; Skin Inflammation/ Irritation

  MAUDE report 11429647 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT CALLED THE IMPLANTING CLINICIAN STATING THAT THE PATIENT'S WHOLE RIGHT ARM AND HAND WAS NUMB, WAS CONFUSED AND HAD DROOL COMING OUT OF RIGHT SIDE OF HIS MOUTH.

  Patient problems: Numbness; Stroke/CVA

  MAUDE report 11399955 ↗
• InjuryDec 24, 2020Electrical Shorting; Electrical Shorting

  ON (B)(6) 2020, THE PATIENT CONTACTED THE CLINICAL REPRESENTATIVE TO REPORTED AN ELECTRICAL BURN SMELL COMING FROM THE WAA CHARGER CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11073286 ↗
• InjuryApr 3, 2020Migration; Migration

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A MIGRATION REPORTED TO STIMWAVE ON MARCH 19, 2020, BY CLINICAL REPRESENTATIVE.

  Patient problems: Erosion

  MAUDE report 9925427 ↗
• InjuryNov 15, 2019Migration; Migration

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM TRIAL DEVICE MIGRATION REPORTED TO STIMWAVE ON OCTOBER 21, 2019.

  Patient problems: No Information

  MAUDE report 9331973 ↗
• MalfunctionOct 30, 2019Material Puncture/Hole; Material Puncture/Hole

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM DEVICE DAMAGED DURING IMPLANT PROCEDURE REPORTED TO STIMWAVE ON (B)(6) 2019.

  Patient problems: Headache

  MAUDE report 9257977 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE PATIENT HAD A TEMPORARY TRIAL PROCEDURE PLACING TWO (2) FREEDOM 8 TRIAL LEADS (FR8A-TRL-A0 AND FR8A-TRL-B0) EPIDURALLY AND EXTERNALIZED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT MET WITH THE CLINICIAN AND TERRITORY MANAGER FOR POST-OPERATIVE FOLLOW-UP EVALUATION AND REPROGRAMMING. THE WOUND DRESSING WAS FOUND TO HAVE PEELED BACK AND DETACHED FROM THE SKIN. THE FR8A-TRL-B0 DEVICE WAS PULLED OUT AT THIS VISIT, BUT THE FR8A-TRL-A0 DEVICE TAIL WAS NO LONGER VISIBLE OUTSIDE THE SKIN. AN X-RAY CONFIRMED THAT THE DEVICE HAD MIGRATED CEPHALAD TO THE C2 VERTEBRA. ON (B)(6) 2019, A NEUROSURGEON EXPLANTED THE DEVICE VIA A LAMINECTOMY WITHOUT COMPLICATION. THE PATIENT REPORTED TO BE IN GOOD HEALTH ON (B)(6) 2019, AND HAS REPORTED NO NEW ISSUES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8711749 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS A RECIPIENT OF THE FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM IN WHICH TWO (2) TRIAL LEADS (FR8A-TRL-A0 AND FR8A-TRL-B0) WERE IMPLANTED IN THE EPIDURAL SPACE TO TREAT PATIENT'S CHRONIC LOWER BACK PAIN. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE AND THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2019 THE PATIENT RETURNED TO THE CLINIC TO HAVE THE TRIAL DEVICES REMOVED. THE IMPLANTING CLINICIAN REPORTED THAT HE WAS ONLY ABLE TO VISUALIZE ONE (1) OUT OF TWO (2) LEADS. THE CLINICIAN SUSPECTED THAT THE SECOND MIGRATED UNDER THE SKIN. BECAUSE THE TRIAL WAS SUCCESSFUL, THE PATIENT ELECTED TO HAVE A PERMANENT DEVICE IMPLANTED THE FOLLOWING (B)(6) 2019. THE CLINICIAN EXPLANTED THE DEVICE THAT WAS VISIBLE, AND DETERMINED THAT HE WOULD RETRIEVE THE MIGRATED DEVICE DURING THE PERMANENT PROCEDURE, AND THE PATIENT CONSENTED TO THIS PROCEDURE. THE PATIENT DID NOT REPORT ANY ADVERSE EFFECTS OR INJURY, AND THE TERRITORY MANAGER REPORTED THE TRIAL MIGRATION TO STIMWAVE ON (B)(6) 2019. ON (B)(6) 2019, X-RAYS REVEALED FURTHER DEVICE MIGRATION. THE IMPLANTING PHYSICIAN WAS NOT AVAILABLE TO EXPLANT THE DEVICE, AND A NEUROSURGEON SUCCESSFULLY EXPLANTED BOTH LEAD

  Patient problems: Pain

  MAUDE report 8388523 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS A RECIPIENT OF THE FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM IN WHICH TWO (2) TRIAL LEADS (FR8A-TRL-A0 AND FR8A-TRL-B0) WERE IMPLANTED IN THE EPIDURAL SPACE TO TREAT PATIENT'S CHRONIC LOWER BACK PAIN. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE AND THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2019 THE PATIENT RETURNED TO THE CLINIC TO HAVE THE TRIAL DEVICES REMOVED. THE IMPLANTING CLINICIAN REPORTED THAT HE WAS ONLY ABLE TO VISUALIZE ONE (1) OUT OF TWO (2) LEADS. THE CLINICIAN SUSPECTED THAT THE SECOND MIGRATED UNDER THE SKIN. BECAUSE THE TRIAL WAS SUCCESSFUL, THE PATIENT ELECTED TO HAVE A PERMANENT DEVICE IMPLANTED THE FOLLOWING MONDAY, (B)(6) 2019. THE CLINICIAN EXPLANTED THE DEVICE THAT WAS VISIBLE, AND DETERMINED THAT HE WOULD RETRIEVE THE MIGRATED DEVICE DURING THE PERMANENT PROCEDURE, AND THE PATIENT CONSENTED TO THIS PROCEDURE. THE PATIENT DID NOT REPORT ANY ADVERSE EFFECTS OR INJURY, AND THE TERRITORY MANAGER REPORTED THE TRIAL MIGRATION TO STIMWAVE ON (B)(6) 2019. ON (B)(6) 2019, X-RAYS REVEALED FURTHER DEVICE MIGRATION. THE IMPLANTING PHYSICIAN WAS NOT AVAILABLE TO EXPLANT THE DEVICE, AND A NEUROSURGEON SUCCESSFULLY EXPLANTED B

  Patient problems: No Code Available

  MAUDE report 8388500 ↗
• InjuryFeb 26, 2019Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT RETURNED TO THE CLINIC FOR A SCHEDULED APPOINTMENT TO HAVE HIS TRIAL LEADS REMOVED. THE PATIENT INFORMED THE TERRITORY MANAGER THAT HE WAS EXPERIENCING SIGNIFICANT PAIN RELIEF DURING THE TRIAL. THE TERRITORY MANAGER ATTEMPTED TO REPROGRAM THE DEVICE DURING THIS APPOINTMENT, BUT WAS UNABLE TO ACHIEVE DESIRED COVERAGE TO TREAT THE PATIENT'S CHRONIC KNEE PAIN. THE CLINICIAN DETERMINED THAT THIS TRIAL WAS UNSUCCESSFUL, AND THE PATIENT WAS NOT A CANDIDATE FOR A PERMANENT DEVICE. THUS, THE PATIENT'S DEVICES WOULD BE EXPLANTED. HOWEVER, WHEN THE CLINICIAN WAS REMOVING THE BANDAGES, HE IDENTIFIED ONLY ONE DEVICE. THE CLINICIAN USED X-RAYS TO VISUALIZE THE IMPLANTED DEVICES, WHICH REVEALED THAT ONE DEVICE MIGRATED TO THE BOTTOM OF THE KNEECAP. THE CLINICIAN WAS ABLE TO EXPLANT BOTH DEVICES COMPLICATION. FOLLOWING EXPLANTATION, THE PATIENT REPORTED NO INJURY FOLLOWING THE TRIAL.

  Patient problems: No Code Available

  MAUDE report 8371128 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT REPORTED EXPERIENCING SOME NECK PAIN AND FOLLOWED UP WITH THE CLINICIAN WHO IMPLANTED THE TRIAL DEVICES FOR A PHYSICAL EXAMINATION. AN X-RAY REVEALED TWO MIGRATED DEVICES; ONE AT C1 AND ANOTHER AT C5. THE PATIENT INFORMED THE CLINICIAN THAT HE WAS CONTINUING TO RECEIVE GOOD COVERAGE AND PAIN RELIEF WITH THE FREEDOM SCS SYSTEM. THE PATIENT FOLLOWED UP WITH THE CLINICIAN AND THE TERRITORY MANAGER WHO PERFORMED THE PERMANENT PROCEDURE ON (B)(6) 2019 FOR EVALUATION AND DEVICE REVISION PLANNING. THE PATIENT DID NOT REPORT ANY OTHER ISSUES WITH THE SYSTEM OR COMPLAINTS OTHER THAN THE NECK PAIN, BUT CONTINUED TO RECEIVE PAIN RELIEF WITH THEIR DEVICE. ON (B)(6) 2019, THE CLINICIAN WHO PERFORMED THE PERMANENT IMPLANT WAS SCHEDULED TO COMPLETE THE DEVICE EXPLANT. DURING THE PROCEDURE, FLUOROSCOPY WAS USED TO VISUALIZE THE MIGRATED DEVICES. THE IMPLANTING CLINICIAN OBSERVED THE TWO DEVICES IN THE CERVICAL REGION, AND ONE DEVICE IN THE THORACIC REGION. THE TERRITORY MANAGER AND THE CLINICIAN CONCLUDED THAT ONE OF THE DEVICES IN THE CERVICAL REGION WAS THE TRIAL DEVICE THAT HAD MIGRATED AND THE SPARE LEAD (FR8A-SPR-B0) FROM THE PERMANENT PROCEDURE. THE RECEIVER STIMU

  Patient problems: No Code Available

  MAUDE report 8281707 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON EXAMINATION OF THE PATIENT AT THE EXPLANT PROCEDURE ON (B)(6) 2018, THE NURSE NOTED POSSIBLE INFECTION AT THE LEAD ENTRY AND SUTURE SITES. ADDITIONAL ANTIBIOTICS (TYPE, DOSAGE, AND DURATION UNKNOWN) WERE PRESCRIBED ON THE DAY OF EXPLANT. ADDITIONALLY, ONE (1) STIMULATOR WAS NOTED TO HAVE MIGRATED CEPHALAD, WITH ONLY THE KNOTTED END REMAINING OUTSIDE OF THE ENTRY POINT. BOTH STIMULATORS WERE EXPLANTED WITHOUT COMPLICATION. THE ANTIBIOTIC PRESCRIPTION PROVIDED AT THE START OF THE TRIAL WAS EXTENDED (DURATION UNKNOWN).

  Patient problems: Post Operative Wound Infection

  MAUDE report 8160166 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A TRIAL PROCEDURE PERFORMED ON (B)(6) 2018, IN WHICH TWO (B)(6) WERE IMPLANTED IN THE EPIDURAL SPACE AT THE T8 TO T9 LEVEL TO TREAT THE PATIENT'S LOW BACK AND LEG PAIN. THE IMPLANTING CLINICIAN WAS AWARE THAT THE PATIENT TAKES A BABY ASPIRIN DAILY AS AN OVER THE COUNTER BLOOD THINNER FOR A COMORBIDITY. AT THE END OF THE TRIAL PERIOD, THE PATIENT REPORTED SIGNIFICANT PAIN RELIEF WITH THE DEVICE AND HIS TRIAL DEVICES WERE REMOVED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT INFORMED THE IMPLANTING CLINICIAN THAT HE STARTED EXPERIENCING NUMBNESS AND WEAKNESS IN HIS LEGS. AN MRI EVALUATION (DATE IS UNKNOWN TO STIMWAVE) REVEALED THAT THE PATIENT HAD FLUID BUILD-UP IN HIS EPIDURAL SPACE. CONCERNED THAT THE PATIENT HAD A HEMATOMA OR SEROMA, THE IMPLANTING CLINICIAN ORDERED IMMEDIATE TREATMENT THROUGH (B)(6) 2018 TO RESOLVE THE ISSUE.

  Patient problems: Hematoma

  MAUDE report 8116833 ↗
• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PROCEDURE PERFORMED ON (B)(6) 2018, IN WHICH TWO (2) FREEDOM-8 TRIAL LEADS (FR8A-TRL-A0, FR8A-TRL) WERE IMPLANTED IN THE SPINAL CORD AT THE L1-L2 LEVEL TO TREAT THE PATIENT'S CHRONIC GROIN PAIN ON HER RIGHT SIDE. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, AND THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2018, THE PATIENT REPORTED TO THE THERAPY SPECIALIST THAT SHE WAS EXPERIENCING PAIN IN HER LEFT SIDE, BUT REDUCING THE STIMULATION AMPLITUDE OF HER SYSTEM RESOLVED HER PAIN. THE PATIENT ALSO STATED THAT SHE HAS SOME POST-OPERATIVE BLEEDING AT OR NEAR THE INCISION SITE, BUT DID NOT COMPLAIN OF ANY OTHER SYMPTOMS. ON (B)(6) 2018, THE THERAPY SPECIALIST MET WITH THE PATIENT TO REPROGRAM THE DEVICE. THE PATIENT DID NOT REPORT ANY ADDITIONAL LEFT SIDE PAIN, AND STATED THAT THE POST-OPERATIVE BLEEDING SUBSIDED. THE PATIENT DID NOT REPORT ANY OTHER SYMPTOMS. ON (B)(6) 2018, THE PATIENT SOUGHT ADDITIONAL CARE AT A HOSPITAL FOR THE PAIN SHE WAS EXPERIENCING IN HERE LEFT SIDE. THE HOSPITAL CONFIRMED AN INFECTION, AND PRESCRIBES IV ANTIBIOTICS (VANCOMYCIN), WHICH REQUIRED HOSPITALIZATION. THE HOSPITAL REMOVED AND DISPOSED OF THE TRIAL DEVICES. THE IMPLANTING CLIN

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 8106029 ↗