Freedom Spinal Cord Stimulator System FR8A-RCV-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00859619004875), received between Feb 16, 2018 and Dec 22, 2025 — classified as 2 deaths, 20 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, 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 ↗
• 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 ↗
• InjuryFeb 25, 2019Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE TERRITORY MANAGER WAS MADE AWARE THAT A PATIENT'S STIMULATOR HAD MIGRATED CAUDALLY FROM ITS PLACEMENT AT THE BACK OF THE SKULL NEAR THE GREATER OCCIPITAL NERVES INTENDED TO TREAT THE PATIENT'S CHRONIC MIGRAINES. THE IMPLANTING CLINICIAN USED X-RAYS TO CONFIRM THE MIGRATION ON (B)(6) 2019. THE TERRITORY MANAGER WAS MADE AWARE AT THIS APPOINTMENT THAT THE PATIENT'S DEVICE WAS NOT PROVIDING THE SAME AMOUNT OF PAIN RELIEF THAT SHE WAS USED TO EXPERIENCING FOLLOWING PERMANENT PROCEDURE ON (B)(6) 2018. AT THIS APPOINTMENT, THE PATIENT DID NOT REPORT ANY NEW PAIN, OTHER SIDE EFFECTS, OR INJURY, THUS THE IMPLANTING CLINICIAN RECOMMENDED THAT THE PATIENT FOLLOW UP ON (B)(6) 2019 TO DETERMINE THE NEXT STEPS FOR THE DEVICE EXPLANT OR REVISION.

  Patient problems: No Code Available

  MAUDE report 8367916 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT CONTACTED THE CLINICAL SPECIALIST AND REPORTED THAT HER LEG WAS SORE AND RED AROUND THE INSERTION SITE. THE PATIENT STATED THAT THE PAIN AND REDNESS PRESENTED SUDDENLY (WITHIN THE LAST 24 HOURS), BUT THE DEVICE WAS STILL PROVIDING PAIN RELIEF. THE CLINICAL SPECIALIST INSTRUCTED THE PATIENT TO SEEK OUT MEDICAL ATTENTION. THE PATIENT MET WITH A PHYSICIAN WHO PRESCRIBED ORAL ANTIBIOTICS (TYPE, DOSE, AND DURATION UNKNOWN). THE THERAPY SPECIALIST SOUGHT MEDICAL ADVISE FROM ANOTHER PAIN SPECIALIST WHO ADVISED THAT IF THE PATIENT HAD AN INFECTION, IT WOULD BE BEST TO SEEK IV ANTIBIOTIC TREATMENT. THE THERAPY SPECIALIST RELAYED THIS INFORMATION TO THE PATIENT, AND AS A PRECAUTION, THE PATIENT VISITED A LOCAL HOSPITAL FOR IV MEDICAL TREATMENT. THE TREATING HOSPITAL TOOK CULTURES OF THE REDDENED SITE TO DETERMINE THE STRAIN OF INFECTION. THE RESULTS OF THESE TESTS ARE UNKNOWN TO STIMWAVE. ON (B)(6) 2018, THE PATIENT REPORTED THAT IV TREATMENT HAD CEASED AND WAS REPLACED WITH BACTROBAN CREAM ON THE SITE AND IS BEING SEALED FROM ENVIRONMENTS TO ENSURE FINALITY OF TREATMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. THE PATIENT CONTINUES TO RECEIVE

  Patient problems: Wound Infection

  MAUDE report 8206348 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A SUCCESSFUL TRIAL WITH THE FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM, THE PATIENT HAD A PERMANENT PROCEDURE PERFORMED ON (B)(6) 2018, IN WHICH A FREEDOM RECEIVER STIMULATOR (FR8A-RCV-A0) AND SPARE LEAD (FR8A-SPR-B0) WAS IMPLANTED IN THE PATIENT'S EPIDURAL SPACE TREAT HIS CHRONIC BACK PAIN. THE RECEIVER STIMULATOR WAS INSERTED SUCCESSFULLY UP TO BODY OF T8; THE EXCESS WAS TUNNELED, AND ANCHORED PER PROCEDURE. THE SPARE LEAD COULD NOT BE INSERTED PAST T10 DUE TO SCAR TISSUE; THE EXCESS WAS TUNNELED, AND ANCHORED PER PROCEDURE. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, AND THE PATIENT WAS RECEIVING AT LEAST 50% PAIN RELIEF. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2018 AND MET WITH THE IMPLANTING CLINICIAN FOR POST-OPERATIVE FOLLOW-UP EVALUATION. AT THIS APPOINTMENT, THE PATIENT REPORTED THAT HE HAD FALLEN TWICE SINCE THE IMPLANT PROCEDURE. STIMWAVE HAS NO INFORMATION ON WHAT CAUSED THE PATIENT TO FALL. THE IMPLANTING CLINICIAN TOOK X-RAYS, WHICH REVEALED THAT THE RECEIVER STIMULATOR HAD MIGRATED TO T5 AND THE SPARE LEAD MIGRATED DOWNWARD AND ANTERIOR. THE CLINICAL SPECIALIST ATTEMPTED TO REPROGRAM THE DEVICES TO RE-ESTABLISH THERAPY. WHILE THE THERAPY WAS RE-

  Patient problems: Fall

  MAUDE report 8125021 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, IN WHICH A STIMQ RECEIVER STIMULATOR (FR8A-RCV-A0) AND SPARE LEAD (FR8A-SPR-B0) WAS IMPLANTED BILATERALLY NEXT TO THE SUPERIOR CLUNEAL NERVE IN THE PATIENT'S BACK TO TREAT THE HIS CHRONIC BACK PAIN. WHILE THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, THE IMPLANTING CLINICIAN WAS NOT COMFORTABLE WITH THE ANCHORING STEP OF THE PROCEDURE. THE CLINICAL SPECIALIST REMINDED THE CLINICIAN THAT ANCHORING MITIGATES MIGRATION, BUT THE IMPLANTING CLINICIAN WAS CONCERNED ABOUT THE POTENTIAL FOR INFECTION. THUS, THE CLINICIAN DEVIATED FROM THE INSTRUCTIONS FOR USE AND DID NOT ANCHOR THE RECEIVER STIMULATOR AND SPARE LEAD ONCE PLACED ALONG THE NERVE. ONCE THE PROCEDURE WAS COMPLETED, THE CLINICAL SPECIALIST PROGRAMMED THE DEVICE AND THE PATIENT REPORTED GOOD PAIN RELIEF AND WAS DISCHARGED THE SAME DAY. ON (B)(6) 2018, THE PATIENT MET WITH THE CLINICAL SPECIALIST AND THE IMPLANTING CLINICIAN FOR A FOLLOW-UP APPOINTMENT AND STATED THAT HE WAS NO LONGER RECEIVING ANY PAIN RELIEF WITH HIS DEVICE. THE IMPLANTING CLINICIAN USED FLUOROSCOPY TO VISUALIZE THE DEVICE, AND IDENTIFIED THAT THE STIMULATOR HAD MIGRATED LATERALLY AWAY FROM THE TARGET SUPERIOR CLUNEAL NERVE.

  Patient problems: No Code Available

  MAUDE report 8120940 ↗
• InjuryNov 30, 2018Improper 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) 2018, THE PATIENT CONTACTED THE IMPLANTING CLINICIAN AND STATED THAT THE DEVICE WAS PROTRUDING FROM HIS SKIN AND WAS CAUSING SOME PAIN. THE PATIENT REPORTED THAT HE CONTINUED TO RECEIVE GOOD PAIN RELIEF WITH THE DEVICE, AND A FOLLOW-UP APPOINTMENT SCHEDULED TO REVISE THE STIMULATOR. THE IMPLANTING CLINICIAN MET WITH THE PATIENT THE SAME DAY AND CONFIRMED THAT THE SPARE LEAD HAD ERODED THROUGH THE PATIENTS SKIN, BUT WAS NOT CAUSING ANY PAIN. THUS, ON (B)(6) 2018, THE IMPLANTING CLINICIAN REVISED THE SPARE LEAD BY "SECURED" THE PROXIMAL END INTO THE SUBCUTANEOUS TISSUE. THE REVISED INCISION WAS CLOSED WITH SUTURES. THE IMPLANTING CLINICIAN DID NOT IDENTIFY ANY INFECTION. THE PATIENT REPORTED GOOD PAIN RELIEF WITH THE DEVICE AND REPORTED NO OTHER COMPLICATIONS OR ISSUES. THE IMPLANTING CLINICIAN DID NOT PRESCRIBE ADDITIONAL ANTIBIOTICS AT THIS APPOINTMENT AS THE PATIENT WAS CONTINUING HIS INITIAL PRESCRIPTION FROM THE IMPLANT PROCEDURE. ON (B)(6) 2018, THE PATIENT BEGAN TO EXPERIENCE PAIN AND WENT TO AN URGENT CARE FOR EVALUATION. THE MEDICAL PROFESSIONALS SUSPECTED THAT THE PATIENT HAD AN INFECTION AND PRESCRIBED ANTIBIOTICS (NAME, DOSE, AND DURATION IS UNKNOWN). FOLLOWING

  Patient problems: Skin Erosion

  MAUDE report 8119989 ↗
• InjuryNov 29, 2018Improper 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) 2018, THE IMPLANTING CLINICIAN CONTACTED THE CLINICAL REPRESENTATIVE TO REPORT THAT THE PROXIMAL END OF ONE OF THE RECEIVER "STIMULATOR" WAS PROTRUDING THROUGH THE PATIENT'S SKIN AT THE INCISION SITE. THE PATIENT REPORTED THAT HE CONTINUED TO RECEIVE GOOD PAIN RELIEF WITH THE DEVICE, AND A FOLLOW-UP APPOINTMENT SCHEDULED TO REVISE THE STIMULATOR. ON (B)(6) 2018, THE IMPLANTING CLINICIAN REVISED THE STIMULATOR BY TRIMMING THE EXPOSED PORTION OF THE STIMULATOR AND SECURED THE PROXIMAL END DEEPER INTO THE FASCIA. THE REVISED INCISION WAS CLOSED WITH SUTURES. THE IMPLANTING CLINICIAN DID NOT IDENTIFY ANY INFECTION. THE PATIENT REPORTED GOOD PAIN RELIEF WITH THE DEVICE AND REPORTED NO OTHER COMPLICATIONS OR ISSUES.

  Patient problems: Skin Erosion

  MAUDE report 8116073 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A SUCCESSFUL TRIAL WITH THE FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM, THE PATIENT HAD A PERMANENT PROCEDURE PERFORMED ON (B)(6) 2018, IN WHICH A FREEDOM-8A RECEIVER STIMULATOR (FR8A-RCV-A0), FREEDOM-8A SPARE LEAD (FR8A-SPR-B0), AND SANDSHARK INJECTABLE ANCHOR (SIA) SYSTEM (SHRK-ALL-1K) WERE IMPLANTED IN THE SPINAL CORD AT THE S1-L5 LEVEL (BILATERAL TRANSGRADE) TO TREAT THE PATIENT'S BILATERAL FOOT PAIN. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, AND THE PATIENT WAS DISCHARGED THE SAME DAY. AT A FOLLOW UP APPOINTMENT WITH THE IMPLANTING CLINICIAN ON (B)(6) 2018 FOR REPROGRAMMING AND INCISION SITE EVALUATION, THE INCISION SITES "WAS" NOTABLY LARGER AND APPEARED INFECTED COMPARED TO THE INCISION SITES AT THE PREVIOUS APPOINTMENT. THE IMPLANTING CLINICIAN SCHEDULED AN EXPLANT OF HER DEVICE THE FOLLOWING DAY BECAUSE THE PATIENT'S INCISION SITES WERE NOT HEALING.

  Patient problems: Post Operative Wound Infection

  MAUDE report 8110942 ↗
• InjuryMay 21, 2018Difficult to Insert; Difficult To Position; Difficult to Insert; Difficult To Position

  THE ADVERSE EVENT OCCURRED IN (B)(6). THE PATIENT WAS IMPLANTED ON (B)(6) 2018 WITH A FREEDOM RECEIVER STIMULATOR (FR8A-RCV-A0) AND SPARE LEAD (FR8A-SPR-B0) FOR NEUROPATHIC LEG PAIN. BEFORE THE PERMANENT PROCEDURE, THE PATIENT SUCCESSFULLY COMPLETED A 10-DAY TRIAL WITH THE FREEDOM SCS SYSTEM TRIAL LEADS. THERE WERE NO COMPLICATION EXPERIENCED DURING THE TRIAL AND THE PATIENT REPORTED ADEQUATE PAIN RELIEF AND NO ISSUES OR ILLNESS DURING THIS PERIOD. THE PATIENT FOLLOWED UP AT A CLINIC ON (B)(6) 2017 AND REPORTED NO ISSUES OR ILLNESS. THE PATIENT WAS SCHEDULED TO RECEIVE A PERMANENT SYSTEM ON (B)(6) 2018. FOLLOWING IMPLANTATION, AND DURING RECOVERY, THE PATIENT REPORTED WEAKNESS IN HER RIGHT LEG. FOLLOWING A CT SCAN, THE IMPLANTING CLINICIAN EXPLANTED THE DEVICES AND REFERRED THE PATIENT TO A NEUROLOGIST ON (B)(6) 2018. THE SPECIALIST WAS INFORMED OF THE EXPLANT ON (B)(6) 2018.

  Patient problems: Weakness

  MAUDE report 7529896 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2017 WITH A FREEDOM RECEIVER STIMULATOR (FR8A-RCV-A0). THERE WERE NO COMPLICATIONS EXPERIENCED DURING THE PROCEDURE AND THE PATIENT WAS SENT HOME THE SAME DAY FOLLOWING RECOVERY AT THE IMPLANTING CLINIC. THE PATIENT WAS PRESCRIBED ANTIBIOTICS (CIPROFLEXIN 500MG 3X/DAY) FOLLOWING IMPLANTATION. OVER THE FOLLOWING THREE (3) MONTHS, THE PATIENT DEVELOPED IRRITATION NEAR THE RECEIVER INCISION. THE PATIENT IS VERY THIN, AND THE LOCATION OF THE RECEIVER INCISION WAS IN CLOSE PROXIMITY TO HER WAIST BAND. THE CLINICIAN CAUTIONED THE PATIENT AGAINST ITCHING THE SITE OR PICKING AT THE WOUND WHILE IT HEALED TO LIMIT POTENTIAL OF INFECTION AND ENCOURAGE WOUND HEALING. ON (B)(6) 2017, THE PATIENT FOLLOWED UP AT THE CLINIC FOR DISCOMFORT AND IRRITATION NEAR THE RECEIVER INCISION AND WAS PRESCRIBED A SECOND COURSE OF ANTIBIOTICS (CIPROFLEXIN 500 MG 3X/DAY). SEQUENTIAL FOLLOW UPS INCLUDED ADDITIONAL ANTIBIOTIC TREATMENT AND AN MRI, WHICH CONFIRMED THAT SHE DID NOT HAVE AN INFECTION. THROUGHOUT ALL THE FOLLOW UPS, THE PATIENT REPORTED NO ISSUES WITH THERAPY, ADEQUATE COVERAGE, AND PAIN RELIEF. AS A PRECAUTION, THE STIMULATOR WAS EXPLANTED ON (B)(6) 2018 TO PREVENT

  Patient problems: Inflammation

  MAUDE report 7277592 ↗