SCS Freedom-8A Trial Neurostimulator Kit Channel A FR8A-TRL-A0Recalls & reported problems
Curonix LLC · SCS Freedom-8A Trial Neurostimulator Kit Channel A · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850051034109), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Shock from Patient Lead(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Use of Device Problem; Use of Device Problem
THE PATIENT REPORTED AN ELECTRICAL SHOCK THROUGHOUT THEIR BODY OVER 15 MINUTES AFTER THE PROGRAMS ON THE TRANSMITTER ASSEMBLY WERE CHANGED. THE PATIENT WAS INSTRUCTED TO TURN THE DEVICE OFF AND RETURN TO THE OFFICE TO CHANGE THE PROGRAMS. THE PROGRAMS ON THE TRANSMITTER WERE CHANGED AGAIN, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL SHOCKS, AND THE DEVICE REMAINED IMPLANTED UNTIL THEIR REGULARLY SCHEDULED APPOINTMENT TO PULL THE TRIAL NEUROSTIMULATOR.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23607449 ↗
Other Stimulator, Spinal-Cord, Implanted (Pain Relief) devices
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- Quattrode™ 3166St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)594 reports
- Swift-Lock™ 1192St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)215 reports
- NA 3386St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)154 reports
- NA 3346St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)117 reports
- Quattrode® 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)81 reports
- Quattrode™ 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)52 reports
- Freedom-8A Receiver Kit Channel A US w/ Receiver FR8A-RCV-A0Stimwave Technologies Incorporated · Stimulator, Spinal-Cord, Implanted (Pain Relief)1 death52 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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