SCS Freedom-8A Permanent Neurostimulator Receiver Kit Channel A FR8A-RCV-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850051034024), received between Jul 24, 2024 and Jul 16, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTEDLY DEVELOPED A STAPHYLOCOCCUS INFECTION DURING AN UNRELATED MINOR SURGICAL PROCEDURE ON (B)(6) 2026 THAT SPREAD TO THE ELECTRODES. CULTURES WERE OBTAINED AND AN INFECTION WAS CONFIRMED, ANTIBIOTICS WERE PRESCRIBED, AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026. THERE WERE NO ALLEGED DEFICIENCIES AND THE PATIENT HAD PERFECT RESULTS WITH THEIR DEVICES. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 25846985 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEY NEVER EXPERIENCED ANY PAIN RELIEF FROM THE NEUROSTIMULATOR. ADDITIONALLY, THE PATIENT REPORTED INCONTINENCE AS WELL AS NAUSEA. SEVERAL ATTEMPTS HAVE BEEN MADE TO CHANGE THE PROGRAMS ON THE TRANSMITTER ASSEMBLY. HOWEVER, THE SYSTEM DID NOT PROVIDE ANY PAIN RELIEF. THE PATIENT WAS INSTRUCTED TO STOP USING THE DEVICE. AS OF (B)(6) 2026, THE PATIENT IS NO LONGER EXPERIENCING URINARY ISSUES OR NAUSEA. AN EXPLANT PROCEDURE WILL BE PERFORMED. HOWEVER, A DATE HAS NOT BEEN PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Nausea; Urinary Incontinence

  MAUDE report 24251052 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED MODERATE INTERNAL TREMORS THROUGHOUT THEIR ENTIRE BODY. THE PATIENT TURNED OFF THEIR DEVICE. HOWEVER, THE TREMORS DID NOT STOP AND THE PATIENT CONTINUED TO USE THE DEVICE. OVER THE NEXT FEW WEEKS, THE PATIENT ALSO DEVELOPED CONSTANT MILD DIZZINESS AND WAS REFERRED TO A NEUROLOGIST. AN X-RAY WAS PERFORMED WHICH REVEALED DEVICES RUNNING THE FULL LENGTH OF THEIR SPINE. THE INTERNAL TREMORS AND DIZZINESS INTENSIFIED AND THE PATIENT DISCONTINUED USE OF THE DEVICE. THE SYMPTOMS HAVE LARGELY RESOLVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 23471367 ↗
• InjuryAug 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2024, THE PATIENT WAS PREPARED FOR THEIR IMPLANT PROCEDURE, RECEIVED GENERAL ANESTHETIC, AND WAS UNDER ANESTHESIA FOR AT LEAST SIXTY MINUTES. THE IMPLANTING CLINICIAN ATTEMPTED TO PLACE THE SPINAL CORD NEUROSTIMULATORS MULTIPLE TIMES WITHOUT SUCCESS. A MICRODISC/LAMINOTOMY PROCEDURE WAS PERFORMED TO HELP INTRODUCE THE NEUROSTIMULATOR INTO THE CANAL. HOWEVER, ADDITIONAL ATTEMPTS AT PLACEMENT WERE UNSUCCESSFUL. IT WAS CONCLUDED THAT THE PATIENT HAS SPINAL STENOSIS AND IT WAS COMPLETELY OBSTRUCTED. THE IMPLANTING CLINICIAN DECLINED TO CONTINUE FURTHER, THE INCISIONS WERE CLOSED, STERILE DRESSINGS WERE APPLIED, AND THE PATIENT WAS TRANSFERRED TO PACU. THE PATIENT WAS STABLE IN THE PACU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072739 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED SHOCKING/JOLTING IN THEIR UPPER SPINE AND LEFT ARM DURING AN MRI. THE MRI WAS ABORTED AND NEW IMAGES AND DIAGNOSTICS WILL BE OBTAINED.

  Patient problems: Electric Shock

  MAUDE report 19822082 ↗
• InjuryJul 24, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED SEVERE PAIN AT THE RECEIVER SITE WHICH DID NOT IMPROVE WITH TIME OR MEDICATIONS. THE PATIENT WAS SENT FOR AN MRI. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Pain

  MAUDE report 19822031 ↗