PNS Freedom-8A Trial Neurostimulator Kit Channel A FR8A-TRL-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00850051034376), received between Nov 1, 2023 and Sep 11, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Expulsion” (2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Use of Device Problem

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 50744258 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED OOZING AT THE INCISION SITE. ANTIBIOTICS WERE PRESCRIBED AS A PRECAUTION AND THE TRIAL DEVICE WAS PULLED ON THEIR REGULARLY SCHEDULED DAY ON (B)(6) 2025. ATTEMPTS WERE MADE TO GATHER INFORMATION ON THE CURRENT PATIENT STATUS. HOWEVER, THE PATIENT HAS NOT CALLED BACK. THE PATIENT IS SCHEDULED FOR THEIR PERMANENT IMPLANT PROCEDURE IN (B)(6). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge

  MAUDE report 23708948 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED MILD SWELLING IN THEIR LEFT HAND/ARM AT THEIR TRIAL LEAD PULL. ALTHOUGH THE TRIAL DEVICE WAS PULLED EARLY ON (B)(6) 2025, THE PATIENT WAS DOING WELL AS FAR AS PAIN RELIEF. AS OF (B)(6) 2025, THE PATIENT IS DOING FINE AND THE SWELLING SUBSIDED AFTER A FEW DAYS.

  Patient problems: Swelling/ Edema

  MAUDE report 23397573 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THE TAPE AND STERILE DRESSING WERE CAUSING ITCHING, BURNING, AND BLISTERS. THE TRIAL DEVICES WERE PULLED EARLY ON (B)(6) 2025. AS OF (B)(6) 2025, THE BLISTERS HAVE RESOLVED.

  Patient problems: Blister; Burning Sensation; Itching Sensation

  MAUDE report 22841834 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE PATIENT'S TRIAL PULL APPOINTMENT, THE PATIENT HAD A MILD SKIN INFECTION AT THE INCISION SITE. ANTIBIOTICS WERE PRESCRIBED AND THE PATIENT WILL FOLLOW-UP IN ONE WEEK FOR REASSESSMENT. THE PATIENT HAD A SUCCESSFUL TRIAL WITH >60% PAIN RELIEF AND WILL BE REFERRED FOR PERMANENT IMPLANT ONCE THE INFECTION HAS CLEARED. THE COMMERCIAL TEAM MEMBER WAS ASKED NOT TO ATTEND THE POST-OP APPOINTMENT. THEREFORE, ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22340880 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED REDNESS, MOISTURE, ITCHING, AND SKIN IRRITATION DUE TO THE TEGADERM USED DURING THEIR TRIAL IMPLANT PROCEDURE. DUE TO THE MOISTURE, THE STERI-STRIP DID NOT STAY IN PLACE AND THE TRIAL DEVICE MOVED OUTSIDE OF THE SKIN. THE DEVICE WAS PULLED AS EXPECTED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 12, 2025. THE AREA WAS CLEANED WITH ALCOHOL AND THE PATIENT WAS INSTRUCTED TO KEEP IT CLEAN AND DRY. THE SKIN ISSUE HAS SINCE RESOLVED.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 22214848 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR INCISION SITE HAD NOT HEALED AND WAS STILL RED AFTER THEIR TRIAL LEAD PULL ON (B)(6) 2025. DURING THE LEAD PULL, THE INCISION SITE WAS CLEANED AND COVERED WITH STERI-STRIPS AND A BANDAGE AND ANTIBIOTICS WERE PRESCRIBED. AS OF (B)(6) 2025, THE INCISION SITE IS STILL A LITTLE RED AND HAS NOT FULLY HEALED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 22214842 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTEDLY EXPERIENCED DIFFICULTY EXPRESSING THEIR WORDS AND TRANSIENT WEAKNESS OF THEIR RIGHT LEG. THE PATIENT WAS ADVISED TO TURN THEIR TRANSMITTER OFF AND GO TO THE HOSPITAL. THE PHYSICIAN MANAGING THE PATIENT'S CARE WAS IMMEDIATELY NOTIFIED. THE PATIENT WENT TO THE EMERGENCY ROOM THE EVENING OF (B)(6) 2025. THE TRIAL DEVICES WERE PULLED WITHOUT DIFFICULTY AND AN MRI WAS REQUESTED. AS OF (B)(6) 2025, THE PATIENT WAS STILL IN THE HOSPITAL AND DECLINED AN MRI. THE COMMERCIAL TEAM MEMBER HAS TRIED TO CONTACT THE PATIENT SEVERAL TIMES WITHOUT SUCCESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22125462 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THEIR INCISION SITE 3-4 WEEKS AFTER THEIR TRIAL IMPLANT PROCEDURE. ON (B)(6) 2025, THE COMMERCIAL TEAM MEMBER CLARIFIED THE AREA OF INFECTION WAS NOT FROM THE TRIAL AS THE INCISION SITE FROM THE TRIAL WAS HEALED. ANTIBIOTICS WERE PRESCRIBED FOR THE AREA OF INFECTION AND THE PATIENT WAS REFERRED TO WOUND CARE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21687752 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT CAME IN TO HAVE THEIR TRIAL NEUROSTIMULATORS PULLED. THE PATIENT CLAIMED THEIR TRIAL NEUROSTIMULATORS FELL OUT WHILE THEY WERE SLEEPING AS THEY WOKE UP AND FOUND THE DEVICES IN THEIR BED. HOWEVER, THE PHYSICIAN BELIEVES THE PATIENT TOOK THE NEUROSTIMULATORS OUT. THE PHYSICIAN ENSURED ALL PARTS OF THE NEUROSTIMULATORS WERE PRESENT AND THE INCISIONS WERE HEALED. THE PATIENT WILL NOT UNDERGO ANOTHER TRIAL PROCEDURE AND WILL NOT BE IMPLANTED WITH A PERMANENT DEVICE.

  Patient problems: Erosion

  MAUDE report 21454198 ↗
• InjuryJan 8, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED BLOOD ON THEIR SHIRT AFTER THEIR TRIAL IMPLANT PROCEDURE. THE PATIENT WAS ADVISED TO APPLY MORE GAUZE AND SECURE IT AS MUCH AS POSSIBLE AND TO GO TO THE EMERGENCY ROOM IF IT DID NOT STOP BLEEDING. THE PATIENT WAS SEEN IN THE OFFICE ON (B)(6) 2024 WHERE THE BANDAGES WERE TAKEN OFF, THE WOUND WAS STILL BLEEDING, AND THE DEVICE WAS PULLED EARLY. THE WOUND WAS CLEANED AND SUTURED SHUT WHICH RESOLVED THE BLEEDING AND THE PATIENT WAS INSTRUCTED TO HOLD THEIR BLOOD THINNERS FOR 72 HOURS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21106158 ↗
• InjuryNov 20, 2024Expulsion; Expulsion

  THE PATIENT REPORTED BLISTERS UNDER THEIR BANDAGE. ADDITIONALLY, THE PATIENT REPORTEDLY FELT A PULL IN THEIR BACK WHILE PULLING THEIR RECLINER UP. ANTIBIOTICS WERE PRESCRIBED AND THE PATIENT WAS PROVIDED INSTRUCTIONS ON HOW TO CARE FOR THE BLISTERS. DURING THEIR FOLLOW-UP APPOINTMENT, IT WAS OBSERVED THAT THE NEUROSTIMULATORS HAD COME OUT OF THE BODY. THE NEUROSTIMULATORS WERE PULLED ON (B)(6) 2024.

  Patient problems: Blister

  MAUDE report 20737917 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A BURNING SENSATION IN THEIR KNEE, AROUND THE NEUROSTIMULATOR, AFTER THEIR IMPLANT PROCEDURE. THE DEVICE WAS OFF FOR TWO DAYS. HOWEVER, THE BURNING SENSATION NEVER WENT AWAY. STEROIDS WERE PRESCRIBED TO TAKE IF THE BURNING SENSATION DID NOT GO AWAY AND THE NEUROSTIMULATOR WAS PULLED EARLY ON (B)(6) 2024. THE PATIENT IS DOING FINE AND THEY ARE NO LONGER EXPERIENCING THE BURNING SENSATION.

  Patient problems: Burning Sensation

  MAUDE report 19629093 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SCHEDULED FOR A NEUROSTIMULATOR PULL ON MAY 29, 2024. HOWEVER, THEY EXPERIENCED A MASSIVE HEART ATTACK THE NIGHT BEFORE THE PROCEDURE. THE PATIENT WAS HOSPITALIZED IN THE ICU AND THE NEUROSTIMULATOR WAS PULLED. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2024 AND WAS SENT TO REHABILITATION. THEY WERE RELEASED FROM THE REHABILITATION FACILITY ON JUNE 14, 2024 AND THEY ARE NOW HOME AND DOING OK.

  Patient problems: Myocardial Infarction

  MAUDE report 19600056 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A REACTION TO THE TRIAL NEUROSTIMULATOR A FEW DAYS INTO THE TRIAL WHICH INVOLVED REDNESS, IRRITATION, AND HEAT AT THE INCISION SITE. THE NEUROSTIMULATORS WERE PULLED PRIOR TO THE ORIGINAL PULL DATE DUE TO THE REACTION (EXACT DATE IS UNKNOWN). A FEW WEEKS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FIVE DAYS DUE TO THE INFECTION. IV ANTIBIOTICS WERE GIVEN IN THE HOSPITAL AND THE PATIENT WILL CONTINUE TAKING ANTIBIOTICS AT HOME FOR 2 WEEKS. THE PATIENT IS HOME AND IS DOING WELL.

  Patient problems: Post Operative Wound Infection; Skin Inflammation/ Irritation

  MAUDE report 19354892 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SOME BLEEDING, LACK OF THERAPY, AND A FEVER AND WAS INSTRUCTED TO GO TO THE EMERGENCY DEPARTMENT. X-RAYS WERE PERFORMED WHICH CONFIRMED MIGRATION. ADDITIONAL TESTING REVEALED THE PATIENT HAD AN EXISTING UTI, CAUSING THE FEVER. THE EMERGENCY DEPARTMENT PHYSICIAN PULLED THE TRIAL NEUROSTIMULATORS ON (B)(6) 2024 AND THE PATIENT IS NOW HEALTHY. HOWEVER, THE PATIENT WILL NOT BE MOVING FORWARD WITH A PERMANENT IMPLANT PROCEDURE.

  Patient problems: Fever; Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 19262311 ↗
• InjuryApr 3, 2024Expulsion; Expulsion

  THE PATIENT REPORTED THAT THE ENTIRE TRIAL NEUROSTIMULATOR CAME OUT OF THEIR SKIN WHILE SLEEPING. THE IMPLANTING PHYSICIAN WORKED WITH THE PATIENT TO MAKE SURE THE INCISIONS WERE CLEAN AND COVERED. THE PATIENT HAS A ROUTINE FOLLOW-UP SCHEDULED WITH THEIR PHYSICIAN TO DISCUSS A RE-TRIAL PROCEDURE.

  Patient problems: Erosion

  MAUDE report 19038977 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED POST-OPERATION SORENESS, BRUISING, AND PAIN. PRECAUTIONARY ANTIBIOTICS WERE PRESCRIBED AND THE LEAD WAS PULLED EARLY ON FEBRUARY 20, 2024. THE PROVIDER REPORTED LOW SUSPICION OF INFECTION BUT ENDORSED BRUISING AND TISSUE TRAUMA IN THE AREA. POST LEAD PULL, THE PATIENT IS STILL SORE BUT IS CONTINUING TO FEEL BETTER, AND THEIR PAIN IS BACK TO BASELINE. ADDITIONALLY, THE PATIENT IS ELECTING TO MOVE TOWARD A PERMANENT IMPLANT AND IS IN THE PROCESS OF GETTING SCHEDULED FOR A PRE-OPERATIVE VISIT WITH THE IMPLANTING CLINICIAN.

  Patient problems: Bruise/Contusion; Pain

  MAUDE report 18917712 ↗
• InjuryMar 5, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE PATIENT REPORTED SOME PAIN AFTER THEIR TRIAL PROCEDURE. THE CLINICAL REPRESENTATIVE STATED THAT THE PATIENT WAS EXPERIENCING NORMAL PROCEDURAL PAIN FROM THE TRIAL AS THE ISSUE WAS REPORTED LESS THAN 24 HOURS AFTER IMPLANTATION. THE PATIENT IS DOING MUCH BETTER, THEY ARE NO LONGER IN PAIN, AND WILL BE MOVING FORWARD TO A PERMANENT IMPLANT.

  Patient problems: Pain

  MAUDE report 18835580 ↗
• InjuryNov 1, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CLINICAL REPRESENTATIVE REPORTED THE ELECTRODE LOCATED AT THE TIP OF THE LEAD HAD FALLEN OFF AND WAS NO LONGER ATTACHED. THE PROVIDER THEN NOTICED THAT THE RECEIVER STYLET WAS POKING OUT THE TIP OF THE LEAD WHERE THE ELECTRODE HAD BEEN. THE RECEIVER WAS ABLE TO COMPLETELY PASS THROUGH THE LEAD AND WAS STICKING OUT THE FRONT INSTEAD OF THE BACK. THE DAMAGED DEVICE WAS NOT IMPLANTED. A NEW LEAD WAS PROVIDED AND WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050220 ↗

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-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
• 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-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-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-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-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