PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel B STQ4-RCV-B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00850051034413), received between Aug 1, 2023 and Sep 15, 2026 — classified as 94 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (37 reports).

6 other recalls cover devices cleared under the same FDA submission (K152178); they may or may not involve this specific model.

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 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Use of Device Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50779315 ↗
• InjurySep 14, 2026Use of Device Problem

  The patient reported an infection near the receiver site. An explant procedure was performed on (b)(6) 2026. No further issues have been reported.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50755773 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50740350 ↗
• InjuryJul 30, 2026Insufficient Device Problem Information

  During an implant procedure, the implanting clinician was unable to get consistent stim artifact and CMAP post suturing. As a result, the patient was under anesthesia for longer than 30 minutes. The neurostimulator was explanted and the implant procedure was aborted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084192 ↗
• InjuryJul 13, 2026Use of Device Problem

  THE PATIENT REPORTED EXTREME PAIN IN THEIR NECK, LOSS OF THERAPY, AS WELL AS NUMBNESS TO THEIR FINGERTIPS ON THE LEFT SIDE. THE PATIENT WAS ADVISED TO CONTINUE USING THE NEUROSTIMULATOR AND CHANGE THE PROGRAMS ON THEIR TRANSMITTER ASSEMBLY, AS NEEDED. ADDITIONALLY, X-RAYS WERE PERFORMED WHICH CONFIRMED DEVICE PLACEMENT. AS OF (B)(6) 2026, THE PATIENT IS DOING WELL AND REPORTED THEIR PAIN GOT BETTER WITH TIME AND THEY DID NOT NEED TO CHANGE THE PROGRAMS ON THEIR TRANSMITTER ASSEMBLY. THE IMPLANTING CLINICIAN ADVISED LIGHT DUTY RESTRICTIONS AND ORDERED PHYSICAL THERAPY. THE PATIENT WILL HAVE A FOLLOW UP APPOINTMENT AFTER PHYSICAL THERAPY HAS BEEN COMPLETED. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Numbness; Pain

  MAUDE report 25807558 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED VIBRATIONS GOING UP THEIR NECK, JAW, AND EAR LOBE WHERE THEY FEEL NUMBNESS WHETHER THE DEVICE IS ON OR OFF. THE COMMERCIAL TEAM MEMBER RECOMMENDED THE PATIENT TAKE A "STIMULATION HOLIDAY" AND SEE A PHYSICIAN TO CHECK FOR DEVICE MIGRATION. AFTER THE "STIMULATION HOLIDAY," THE PATIENT REPORTED THE NUMBNESS WAS THE SAME. HOWEVER, IT DOES HELP WITH THEIR CHRONIC NECK PAIN. AS OF (B)(6) 2026, THE PATIENT IS DOING FINE AND SAW AN ORTHOPEDIC PHYSICIAN WHERE IMAGES WERE TAKEN. HOWEVER, RESULTS OF THE IMAGING HAVE NOT BEEN PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Numbness

  MAUDE report 25612574 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED IMPAIRED HEALING AT THE RECEIVER SITE. ANTIBIOTICS WERE PRESCRIBED AND AS OF ON (B)(6) 2026, THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN WOUND HEALING. ADDITIONALLY, THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT WITH >90% PAIN RELIEF. AS OF ON (B)(6) 2026, THE WOUND IS CLOSED, THE PATIENT COMPLETED THEIR ANTIBIOTICS AND CONTINUES TO USE THE NEUROSTIMULATOR AND REPORTED SIGNIFICANT IMPROVEMENT IN KNEE PAIN. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Impaired Healing

  MAUDE report 25587894 ↗
• InjuryJun 12, 2026Use of Device Problem

  THE PATIENT REPORTED NOT GETTING MUCH PAIN RELIEF SINCE THEIR IMPLANT PROCEDURE. ADDITIONALLY, THE PATIENT STARTED FEELING A NEW STABBING FEELING ON THEIR RIGHT SIDE. AS OF (B)(6) 2026, THE PATIENT REPORTED THE PAIN REMAINS THE SAME. A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2026. HOWEVER, THE PATIENT DID NOT SHOW UP. THE COMMERCIAL TEAM MEMBER CALLED THE PATIENT. HOWEVER, THEY HAVE NOT RECEIVED A CALL BACK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 25487301 ↗
• InjuryJun 11, 2026Use of Device Problem

  THE PATIENT REPORTED PAIN AND PULLED OUT A STITCH FROM THE RECEIVER SITE WHICH CAUSED THE POCKET TO OPEN. CULTURES WERE OBTAINED AND AN INFECTION WAS NOT CONFIRMED. A REVISION OF THE POCKET WILL BE PERFORMED. HOWEVER, A DATE HAS NOT BEEN PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 25480124 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED TENDERNESS AT THE INCISION SITE AFTER THEIR IMPLANT PROCEDURE. ON (B)(6) 2026, THE PATIENT EXPRESSED THAT THEIR TOP INCISION WAS STILL SORE AS WELL AS A "POKING" FEELING. ON (B)(6) 2026, THE PATIENT WENT TO THE EMERGENCY ROOM WHERE IT WAS CONFIRMED THEY COULD SEE THE COIL FROM UNDER THE MAIN INCISION AS WELL AS SOME SWELLING. X-RAYS WERE PERFORMED WHICH SHOWED NOTHING ABNORMAL. AS OF ON (B)(6) 2026, THE PATIENT IS STILL FEELING THE "POKING" SENSATION AND WILL ATTEND THEIR FOLLOW UP APPOINTMENT ON (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 25478572 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THE INCISION SITE. ANTIBIOTICS WERE PRESCRIBED AND AS OF (B)(6) 2026, THE INFECTION IS ALMOST GONE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25399532 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SWELLING IN BOTH OF THEIR LEGS AFTER THEIR IMPLANT PROCEDURE. ANTIBIOTICS WERE PRESCRIBED AFTER THE IMPLANT PROCEDURE AS A PREVENTATIVE AND THE PATIENT CONTINUED TO TAKE THEM AS PLANNED. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE I.V. FLUIDS WERE ADMINISTERED AND A LEG COMPRESSION MACHINE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND WAS DISCHARGED ON (B)(6) 2026. AS OF (B)(6) 2026, THE SWELLING HAS RESOLVED, AND THE PATIENT IS RECEIVING THERAPY. NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 25393804 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A POSSIBLE INFECTION OR ALLERGY AS THERE WAS IRRITATION AROUND THE IMPLANT SITE. ANTIBIOTICS WERE PRESCRIBED, CULTURES WERE OBTAINED, AND AN ALLERGY PANEL WAS PERFORMED. THE CULTURE RESULTS AND ALLERGY PANEL CAME BACK NEGATIVE. ON (B)(6) 2026, AN EXPLANT PROCEDURE WAS PERFORMED DUE TO THE IRRITATION. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25365402 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR INCISION SITE SUDDENLY SWELLED UP AND BECAME "HARD" WITH MILD PAIN. ANTIBIOTICS WERE PRESCRIBED ON (B)(6) 2026. THE PATIENT FOLLOWED UP ON (B)(6) 2026 AND NOTED THE SWELLING IMPROVED AND THEY HAVE ADHERED TO TAKING THEIR ANTIBIOTICS AND DISCONTINUED USE OF THE NEUROSTIMULATOR UNTIL THE AREA HAS HEALED. THE PATIENT ATTENDED AN ADDITIONAL FOLLOW-UP APPOINTMENT ON (B)(6) 2026. THE PATIENT WAS INSTRUCTED HOW TO CLEAN THE WOUND APPROPRIATELY AS WELL AS HOW TO COVER THE WOUND WHILE WORKING AND THEY WERE CLEARED FROM SERIOUS INFECTION. IT WAS NOTED THE PATIENT WAS DOING WELL OVERALL, THE SWELLING WAS GONE, THE WOUND HAD SCABBED OVER WITH MINIMAL DRAINAGE, AND THE PATIENT MAY CONTINUE USE OF THE DEVICE WHILE COVERING THE INCISION WITH A BANDAGE. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 28, 2026. THE COMMERCIAL TEAM MEMBER REPORTED THE INCISION SITE RE-OPENED AND THE NEUROSTIMULATOR WAS VISIBLE AND THE IMPLANTING CLINICIAN WAS NOTIFIED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge; Pain; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25322364 ↗
• InjuryMay 22, 2026Use of Device Problem

  THE PATIENT REPORTED PAIN IN THEIR KNEE DUE TO A BLISTER AT THE RECEIVER SITE, AFTER THEIR DOG SCRATCHED THEM. ON (B)(6) 2026, THE PROVIDER OBSERVED A LARGE ABSCESS AT THE RECEIVER SITE AND AN EXPLANT PROCEDURE WAS SCHEDULED FOR (B)(6) 2026. HOWEVER, THE EXPLANT PROCEDURE WAS CANCELLED, AS WELL AS THE RESCHEDULED EXPLANT PROCEDURE ON (B)(6) 2026 AS THE PATIENT DID NOT SHOW UP. ON (B)(6) 2026, THE PATIENT WENT TO THE EMERGENCY ROOM WHERE THE ABSCESS WAS LANCED. ON (B)(6) 2026, ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED. AS OF (B)(6) 2026, THE COMMERCIAL TEAM MEMBER HAS TRIED CONTACTING THE PATIENT REGARDING THE STATUS OF THE BLISTER AND ABSCESS SEVERAL TIMES. HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Abscess; Blister; Pain

  MAUDE report 25260937 ↗
• InjuryMay 14, 2026Use of Device Problem

  THE PATIENT REPORTED THEIR NON-CURONIX SCS TRIAL DEVICE INTERFERED AND IRRITATED THEIR CURONIX PNS DEVICES. THE PATIENT NOTED THE NON-CURONIX SCS IMPLANT CAUSED EXTREME PAIN WHERE THE PNS DEVICES ARE IMPLANTED AND REQUESTED AN EXPLANT PROCEDURE OF THEIR CURONIX DEVICES. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026.

  Patient problems: Pain

  MAUDE report 25166897 ↗
• InjuryMay 11, 2026Expulsion

  THE PATIENT REPORTED EROSION OF THE NEUROSTIMULATOR OUT OF THEIR SKIN. AS OF (B)(6) 2026, AN EXPLANT DATE HAS NOT YET BEEN SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Erosion

  MAUDE report 25135644 ↗
• InjuryMay 7, 2026Expulsion

  THE PATIENT REPORTED THEIR NEUROSTIMULATOR WAS BROKEN IN HALF AND ERODED THROUGH THEIR SKIN. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026. THE DEVICE APPEARED FRACTURED ABOVE THE CIRCUITRY AFTER THE EXPLANT PROCEDURE. THE NEUROSTIMULATOR WAS REMOVED AND THERE WERE NO BROKEN OR FRACTURED PIECES LEFT IMPLANTED. AS OF (B)(6) 2026, THE PATIENT IS HEALING AND DOING WELL.

  Patient problems: Erosion

  MAUDE report 25113748 ↗
• InjuryMay 7, 2026Migration

  THE PATIENT REPORTED A LOSS OF THERAPY AND NEW PAIN IN THEIR ANKLE JOINT. AN X-RAY WAS PERFORMED WHICH CONFIRMED MIGRATION OF THE NEUROSTIMULATOR. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026. THE PAIN IN THE ANKLE JOINT HAS SOMEWHAT IMPROVED AFTER THE EXPLANT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 25113745 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED BEING HOSPITALIZED DUE TO A SUSPECTED BLOOD INFECTION. ON FEBRUARY 24, 2026, THE PATIENT CLARIFIED THAT THEY WERE EVALUATED AT URGENT CARE AND WERE NOT HOSPITALIZED. ADDITIONALLY, THE PATIENT CLARIFIED THAT THEY WERE EVALUATED AT URGENT CARE DUE TO A SUSPECTED WOUND INFECTION. HOWEVER, IT WAS DETERMINED THE WOUND WAS OKAY. MEDICAL INTERVENTION WAS NOT PERFORMED AND A BLOOD INFECTION WAS NOT CONFIRMED. AS OF FEBRUARY 24, 2026, THE PATIENT IS DOING FINE WITH NO ISSUES.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24521685 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  ON FEBRUARY 18, 2026, THE COMMERCIAL TEAM MEMBER WAS INFORMED THAT AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026 DUE TO A POTENTIAL INFECTION AT THE INCISION SITE. CULTURES WERE OBTAINED. HOWEVER, AN INFECTION WAS NOT CONFIRMED. A NEW NEUROSTIMULATOR WAS IMPLANTED ON (B)(6) 2026, AND THE PATIENT IS DOING WELL.

  Patient problems: Skin Infection

  MAUDE report 24521684 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SEVERE BACK PAIN AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026. IV PAIN MEDICATION WAS PRESCRIBED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE COMMERCIAL TEAM MEMBER MET WITH THE PATIENT TO REITERATE PROPER USE OF THE TRANSMITTER ASSEMBLY AND CHANGED THE PROGRAMS ON THE TRANSMITTER ASSEMBLY. THE COMMERCIAL TEAM MEMBER MET WITH THE PATIENT ON (B)(6) 2026, WHO STATED THERE WAS NO CHANGE SINCE THE RECENT REPROGRAMMING. THE PATIENT WILL BE SCHEDULING AN X-RAY SOON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Back pain

  MAUDE report 24457484 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR INCISION AT THE RECEIVER SITE BECAME VERY MOIST AND OPENED UP. THE PATIENT MET WITH THE IMPLANTING CLINICIAN AND THE INCISION WAS FLUSHED WITH STERILE SALINE AND ALCOHOL AND CHLOROPREP WERE USED AROUND THE INCISION. STERILE GAUZE WAS USED TO PAT DOWN THE EXCESS SOLUTION AND THE INCISION WAS CLOSED WITH STERI-STRIPS AND COVERED WITH TEGADERM. AS OF (B)(6) 2026, THE INCISION HAS FULLY HEALED WITH NO SIGNS OF IRRITATION, REDNESS, OR INFECTION.

  Patient problems: Wound Dehiscence

  MAUDE report 24403207 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR DEVICE HAS NEVER WORKING PROPERLY AND IS NOW CAUSING BAD SHOCKS DOWN THEIR LEG. THE PATIENT WAS SCHEDULED TO MEET WITH THE COMMERCIAL TEAM MEMBER TO TROUBLESHOOT ON (B)(6) 2026. HOWEVER, THE PATIENT CANCELLED THE MORNING OF AND THE APPOINTMENT WAS RESCHEDULED FOR (B)(6) 2026. THE PATIENT CANCELLED THE APPOINTMENT ON (B)(6) 2026 AND STATED THEY DID NOT WANT TO RESCHEDULE THE APPOINTMENT AT THIS TIME. THE PATIENT IS NOT CURRENTLY USING THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24148065 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED REDNESS AND SOME DRAINAGE AT THE RECEIVER SITE. HOWEVER, THERE WAS NO ODOR REPORTED. THE PATIENT HAD LIMITED USE OF NEUROSTIMULATOR, PER THE IMPLANTING CLINICIAN, FOLLOWING THE POST-OP VISIT TO ALLOW FOR HEALING. ON (B)(6) 2025, THE PATIENT SLOWLY BEGAN TO INCREASE USAGE OF THE DEVICE. AS OF (B)(6) 2026, THE WOUND IS HEALING, THE PATIENT IS RECEIVING THERAPY, AND THE INCISIONS WERE NOT INFECTED.

  Patient problems: Erythema; Fluid Discharge

  MAUDE report 24025435 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152178. One submission often covers many models, so check the product and lot details in each record.

• Z-2928-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relie
• Z-2932-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractabl
• Z-2930-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief
• Z-2929-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractabl
• Z-2933-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic re
• Z-2931-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractab