Freedom System Accessories PDBT-915-2KRecalls & reported problems
Curonix LLC · Transmitter Assembly (915MHz) · Class 2 · Implant
All models of Freedom System Accessories (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Curonix Freedom System transmitter assembly is an implanted spinal cord stimulator part that sends signals over a 915MHz connection. Most of the 33 reports describe the unit getting hot while charging or worn on the skin, leading to burning sensations, rashes and shocks felt through the leads. Twenty-nine reports describe injuries and no deaths were reported; some patients received replacement transmitters. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00850051034550), received between Jun 5, 2024 and Sep 24, 2026 — classified as 29 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (14 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem14
- Adverse Event Without Identified Device or Use Problem10
- Defective Component6
- Detachment of Device or Device Component6
- Electrical /Electronic Property Problem2
- Circuit Failure1
- Manufacturing, Packaging or Shipping Problem1
- Moisture Damage1
Patient problems
- Burning Sensation17
- Shock from Patient Lead(s)6
- No Clinical Signs, Symptoms or Conditions5
- Electric Shock4
- Rash2
- Blister1
- Burn(s)1
- Skin Burning Sensation1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888692 ↗MalfunctionAug 3, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113077 ↗MalfunctionMay 28, 2026Defective Component
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WOULD NOT CHARGE DESPITE USING THE USB CHARGER AND CABLE PROVIDED TO RECHARGE THE TRANSMITTER. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY AND NO FURTHER ISSUES HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323354 ↗MalfunctionMay 14, 2026Use of Device Problem
THE PATIENT REPORTED THE TRANSMITTER ASSEMBLY EMITTED A BURNING SMELL AND GOT EXTREMELY HOT WHILE CHARGING. HOWEVER, THE OVERHEATING DID NOT CAUSE A BURNING SENSATION TO THE SKIN OR TISSUE DAMAGE AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. THE PATIENT ALSO REPORTED THE DEVICE WOULD NO LONGER CHARGE. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175001 ↗MalfunctionMay 14, 2026Use of Device Problem
THE PATIENT REPORTED THE TRANSMITTER ASSEMBLY EMITTED A BURNING SMELL AND GOT EXTREMELY HOT WHILE CHARGING. HOWEVER, THE OVERHEATING DID NOT CAUSE A BURNING SENSATION TO THE SKIN OR TISSUE DAMAGE AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. THE PATIENT ALSO REPORTED THE DEVICE WOULD NO LONGER CHARGE. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166910 ↗InjuryApr 14, 2026Defective Component; Detachment of Device or Device Component
THE PATIENT REPORTED REDNESS AND A RASH ON THEIR SKIN UNDER WHERE THE TRANSMITTER ASSEMBLY IS WORN. ADDITIONALLY, THE PATIENT REPORTED THEY FEEL WARMTH FROM THE TRANSMITTER ASSEMBLY AND A BURNING SENSATION TO THE SKIN. HOWEVER, THE BURNING SENSATION DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. AS OF (B)(6) 2026, THE RASH HAS RESOLVED COMPLETELY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY, AND THE PATIENT IS DOING WELL.
Patient problems: Burning Sensation; Rash
MAUDE report 24876799 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED REDNESS AND A RASH ON THEIR SKIN UNDER WHERE THE TRANSMITTER ASSEMBLY IS WORN. ADDITIONALLY, THE PATIENT REPORTED WARMTH FROM THE TRANSMITTER ASSEMBLY WHICH CAUSED A BURNING SENSATION TO THE SKIN. HOWEVER, THE BURNING SENSATION DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. AS OF (B)(6) 2026, THE RASH HAS RESOLVED COMPLETELY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY, AND THE PATIENT IS DOING WELL.
Patient problems: Rash; Skin Burning Sensation
MAUDE report 24794177 ↗InjuryMar 17, 2026Use of Device Problem
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS GETTING HOT AND CAUSED A BURNING SENSATION TO THE SKIN. TOPICAL OINTMENT WAS USED AND AS OF (B)(6) 2026, THE SKIN IS HEALING. ADDITIONALLY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY. THE PATIENT HAS A FOLLOW UP APPOINTMENT ON (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Burning Sensation
MAUDE report 24618695 ↗InjuryMar 17, 2026Use of Device Problem
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS GETTING HOT AND CAUSED A BURNING SENSATION TO THE SKIN. TOPICAL OINTMENT WAS USED AND AS OF (B)(6) 2026, THE SKIN IS HEALING. ADDITIONALLY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY. THE PATIENT HAS A FOLLOW UP APPOINTMENT ON (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Burning Sensation
MAUDE report 24618692 ↗InjuryFeb 20, 2026Use of Device Problem
THE PATIENT REPORTED A BURNING SENSATION AND A BLISTER ON THEIR SKIN UNDERNEATH THEIR TRANSMITTER ASSEMBLY. THE PATIENT HAS BEEN USING THEIR OTHER TRANSMITTER ASSEMBLY AND IS NOW WEARING THE WEARABLE OVER A SOCK. AS OF (B)(6) 2026, THE BLISTER HAS CLEARED UP AND THE PATIENT HAS NOT EXPERIENCED ANY ADDITIONAL BURNING SENSATIONS.
Patient problems: Blister; Burning Sensation
MAUDE report 24403208 ↗InjuryDec 22, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
THE PATIENT REPORTED A BURNING SENSATION FROM THEIR TRANSMITTER ASSEMBLY. HOWEVER, THE BURNING SENSATION DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.
Patient problems: Burning Sensation
MAUDE report 23873290 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY GETS HOT AND CAUSED A BURNING SENSATION TO THE SKIN. HOWEVER, THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION.
Patient problems: Burning Sensation
MAUDE report 23790567 ↗InjuryDec 3, 2025Circuit Failure; Moisture Damage; Defective Component; Circuit Failure; Moisture Damage; Defective Component
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS OVERHEATING AND CAUSED A BURNING SENSATION TO THE SKIN. HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY DAMAGE TO THE SKIN OR REQUIRE MEDICAL INTERVENTION. THE PATIENT TURNED OFF THE DEVICE AND STOPPED USING IT.
Patient problems: Burning Sensation
MAUDE report 23712191 ↗InjuryOct 20, 2025Defective Component; Defective Component
THE PATIENT REPORTED A SHOCKING SENSATION FROM ONE OF THEIR TRANSMITTER ASSEMBLIES. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY, THE PROGRAMS WERE CHANGED, AND THEY HAVE NOT EXPERIENCED ADDITIONAL SHOCKING SENSATIONS.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23339525 ↗InjuryOct 20, 2025Use of Device Problem; Use of Device Problem
THE PATIENT REPORTED A SHOCKING SENSATION WHEN USING ONE OF THEIR TRANSMITTER ASSEMBLIES. THE PROGRAMS ON THE TRANSMITTER ASSEMBLY WERE CHANGED AND THE PATIENT HAS BEEN USING THEIR OTHER TRANSMITTER. NO FURTHER ISSUES OF SHOCKING SENSATIONS HAVE BEEN REPORTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23339448 ↗InjurySep 5, 2025Use of Device Problem; Use of Device Problem
THE PATIENT REPORTEDLY GOT SHOCKED. THE PROGRAMS ON THE TRANSMITTER ASSEMBLY WERE CHANGED BY LOWERING THE AMPLITUDE. AS OF (B)(6) 2025, THE PATIENT HAS NOT EXPERIENCED ANY ADDITIONAL SHOCKS AFTER LOWERING THE AMPLITUDE, THEY ARE GETTING GOOD PAIN RELIEF, AND FEELING VERY GOOD.
Patient problems: Shock from Patient Lead(s)
MAUDE report 22978957 ↗InjuryAug 15, 2025Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED A BURNING SENSATION WHILE USING THEIR DEVICE. THE BURNING SENSATION WAS RELIEVED WITHIN MINUTES OF REMOVING THE WEARABLE. AS OF (B)(6) 2025, THE PATIENT IS USING THEIR OTHER TRANSMITTER ASSEMBLY, THEY HAVE NOT REPORTED ANOTHER INCIDENT OF A BURNING SENSATION, AND THEY HAVE RETURNED TO BASELINE.
Patient problems: Burning Sensation
MAUDE report 22816686 ↗InjuryJul 21, 2025Defective Component; Defective Component
THE PATIENT REPORTED ONE OF THEIR TRANSMITTER ASSEMBLIES GIVES THEM A BREAKTHROUGH PARESTHESIA SENSATION. TWO DIFFERENT ANTENNAS WERE USED. HOWEVER, THE PATIENT EXPERIENCED THE SAME SENSATION. AS OF (B)(6) 2025, THE PATIENT HAS BEEN USING THEIR OTHER TRANSMITTER ASSEMBLY WHICH HAS RESOLVED THE REPORTED ISSUE. ADDITIONALLY, THE PATIENT WAS PROVIDED A NEW TRANSMITTER ASSEMBLY WHICH THEY WILL SOON BEGIN TO USE.
Patient problems: Shock from Patient Lead(s)
MAUDE report 22556261 ↗InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS GETTING HOT AND CAUSED A BURNING SENSATION TO THE SKIN. HOWEVER, THE BURNING SENSATION DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION.
Patient problems: Burning Sensation
MAUDE report 22500735 ↗InjuryJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT REPORTED SHOCKING SENSATIONS FROM THEIR TRANSMITTER ASSEMBLY ON ALL PROGRAM LEVELS. THE SHOCKING SENSATIONS WERE RESOLVED BY USING THEIR OTHER TRANSMITTER ASSEMBLY.
Patient problems: Shock from Patient Lead(s)
MAUDE report 22331669 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED A BURNING SENSATION IN THEIR FOOT WHEN TURNING THE DEVICE ON. SEVERAL ATTEMPTS HAVE BEEN MADE TO CHANGE THE PROGRAMS ON THE TRANSMITTER ASSEMBLY WITH NO CHANGE AS THE PATIENT IS STILL EXPERIENCING A BURNING SENSATION WITHIN 10-20 MINUTES OF HAVING THE DEVICE TURNED ON WITH LOWEST SETTINGS POSSIBLE. ADDITIONALLY, THE PATIENT REPORTED A DISCOLORATION ON THEIR ANKLE CLOSE TO THE DEVICE. HOWEVER, IT HAS RESOLVED. AS OF JUNE 16, 2025, THE PATIENT REPORTED THE SENSATIONS HAVE SLOWLY GONE AWAY AFTER HAVING THE DEVICE TURNED OFF FOR A FEW DAYS.
Patient problems: Burning Sensation
MAUDE report 22331597 ↗InjuryJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT REPORTED RECEIVING ZAPPING/SHOCKING SENSATIONS FROM THEIR TRANSMITTER ASSEMBLY WHEN THEY SIT UP OR BEND DOWN. THE PATIENT WAS PROVIDED A LOANER TRANSMITTER ASSEMBLY AND HAS BEEN DOING GREAT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 22331523 ↗InjuryApr 17, 2025Use of Device Problem; Use of Device Problem
THE PATIENT REPORTEDLY FELT A BURNING SENSATION ON THEIR BACK WHILE WEARING THE TRANSMITTER ASSEMBLY. ADDITIONALLY, THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY AND CORD WERE BOTH HOT. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION AND WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY. NO FURTHER ISSUES HAVE BEEN REPORTED.
Patient problems: Burning Sensation
MAUDE report 21859664 ↗InjuryApr 17, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY HEATS UP AND CAUSES A BURNING SENSATION TO THE SKIN. HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY AND NO FURTHER ISSUES HAVE BEEN REPORTED.
Patient problems: Burning Sensation
MAUDE report 21858986 ↗InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS OVERHEATING AND CAUSED A BURNING SENSATION TO THE SKIN. HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY DAMAGE TO THE SKIN OR REQUIRE MEDICAL INTERVENTION.
Patient problems: Burning Sensation
MAUDE report 21577119 ↗
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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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