Freedom-4A Trial Kit Channel B US w/ Receiver FR4A-TRL-B0Recalls & reported problems
Stimwave Technologies Incorporated · Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel B US w/ Receiver · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818225020587), received between May 21, 2021 and Aug 1, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Expiration Date Error” (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
Device problems
- Expiration Date Error1
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- Erosion1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2021Improper or Incorrect Procedure or Method; Expiration Date Error
THE DEVICE WAS IMPLANTED AFTER THE DEVICE'S EXPIRATION DATE.
Patient problems: Insufficient Information
MAUDE report 12257341 ↗InjuryMay 21, 2021Insufficient Device Problem Information
ON (B)(6) 2021, THE IMPLANTING CLINICIAN PERFORMED AN EXPLANT PROCEDURE TO REMOVE THE STIMULATOR.
Patient problems: Erosion
MAUDE report 11867354 ↗
Other Stimulator, Spinal-Cord, Implanted (Pain Relief) devices
- Octrode™ 3086St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)30 deaths1,538 reports
- 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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