PNS Freedom-4A Trial Neurostimulator Kit Channel A FR4A-TRL-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00850051034369), received between Aug 29, 2023 and Sep 17, 2026 — classified as 1 death, 16 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported bleeding at the incision site after their trial implant procedure. The patient went to the hospital, the bandages were removed, the STERIS-Strips were left in tact, pressure was applied to stop the bleeding, and the wound was redressed in order for the patient to continue the trial. As of (b)(6)2026, the bleeding has stopped.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50808902 ↗
• InjuryDec 15, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED REDNESS AND SKIN IRRITATION AFTER THEIR TRIAL NEUROSTIMULATOR WAS PULLED. THE PATIENT WAS TREATED BY URGENT CARE AND ANTIBIOTICS WERE PRESCRIBED. A STAPH INFECTION WAS IDENTIFIED AND THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT WHERE IV ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS ALLERGIC TO THE FIRST ANTIBIOTIC. HOWEVER, THE SECOND ANTIBIOTIC CLEARED UP THE INFECTION. THE PATIENT WILL BE MOVING FORWARD WITH THE PERMANENT IMPLANT ALTHOUGH THE IMPLANTING CLINICIAN WANTS TO WAIT A FEW MONTHS TO ENSURE SAFETY.

  Patient problems: Bacterial Infection; Skin Inflammation/ Irritation

  MAUDE report 23809955 ↗
• InjuryOct 27, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED AN INFECTION AT THE INCISION SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6), 2025 AND WAS GIVEN IV ANTIBIOTICS. THE TRIAL LEADS WERE PULLED EARLY ON (B)(6) 2025, AND THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2025. AS OF (B)(6) 2025, THE INFECTION IS UNDER CONTROL. HOWEVER, IT IS NOT CLEAR IF THE INFECTION HAS COMPLETELY CLEARED UP.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23397572 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A TRIAL NEUROSTIMULATOR ON (B)(6) 2025 AND REPORTED GREAT PAIN RELIEF. HOWEVER, ON (B)(6) 2025, THE PATIENT WAS NAUSEOUS, WEAK, AND COMMUNICATING POORLY. THE PATIENT WAS TAKEN TO THE HOSPITAL TO THE ICU DEPARTMENT.

  Patient problems: Muscle Weakness/Atrophy; Nausea

  MAUDE report 21687692 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT ONE OF THEIR INCISION SITES. ANTIBIOTICS WERE PRESCRIBED, AND AS OF (B)(6) 2025, THE PATIENT IS DOING WELL AND THEIR INFECTION IS GONE AND HEALED. THE PATIENT CONTINUES TO WEAR THEIR DEVICE.

  Patient problems: Skin Infection

  MAUDE report 21647072 ↗
• InjuryDec 5, 2024Fracture; Use of Device Problem; Fracture; Use of Device Problem

  THE IMPLANTING CLINICIAN INADVERTENTLY CLIPPED THE NEUROSTIMULATOR INSTEAD OF THE SUTURE DURING A TRIAL LEAD PULL. A PORTION OF THE NEUROSTIMULATOR REMAINS IMPLANTED IN THE BODY AND WILL BE REMOVED DURING THE PERMANENT IMPLANT PROCEDURE (DATE HAS NOT BEEN SCHEDULED). ANTIBIOTICS WERE PRESCRIBED AS A PREVENTATIVE MEASURE, THE PATIENT IS DOING WELL, AND THEY ARE NOT EXPERIENCING PAIN OR SIGNS OF INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857881 ↗
• InjuryNov 20, 2024Off-Label Use; Off-Label Use

  THE PATIENT WAS SCHEDULED FOR A NEUROSTIMULATOR PULL ON (B)(6) 2024. DURING THE PROCEDURE, THE OCCIPITAL NEUROSTIMULATOR WAS PULLING WHICH CAUSED THE INCISION TO BECOME RED, ITCHY, AND IRRITATED. ANTIBIOTICS WERE PRESCRIBED AND A BANDAGE WAS PLACED ON THE INCISION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20739816 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO BLEEDING. THE TRIAL NEUROSTIMULATOR WAS PULLED EARLY ON (B)(6) 2024 AND THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20386061 ↗
• InjuryOct 2, 2024Use of Device Problem; Use of Device Problem

  DURING THE TRIAL IMPLANT PROCEDURE, THE YELLOW INTRODUCER SPLIT IN HALF INSIDE OF THE PATIENT'S SKIN. THE IMPLANTING CLINICIAN WAS ABLE TO SAFELY REMOVE THE HALF THAT WAS STUCK UNDER THE PATIENT'S SKIN AND THE PROCEDURE WAS COMPLETED USING A COUDE NEEDLE. THE PATIENT IS DOING WELL AND WILL BE MOVING FORWARD WITH A PERMANENT IMPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355493 ↗
• DeathSep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE COMMERCIAL TEAM MEMBER ATTEMPTED TO FOLLOW-UP WITH THE PATIENT REGARDING THEIR TRIAL AND WAS INFORMED THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2024. THE COMMERCIAL TEAM MEMBER LAST SPOKE WITH THE PATIENT ON (B)(6) 2024 AND THEY WERE DOING WELL WITH THE TRIAL AND GETTING GREAT RELIEF IN THEIR BACK. UPON NOTIFYING THE PHYSICIANS OFFICE OF THE PATIENT'S DEATH, THE PHYSICIAN REPORTED THE PATIENT HAD A FUNGAL INFECTION THAT HAD CAUSED THE PATIENT TO LOSE A LOT OF WEIGHT. THE PATIENT WANTED TO PURSUE THE PNS TRIAL AS A MEANS OF TREATING THEIR BACK PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252715 ↗
• InjuryAug 14, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED BURNING IN THEIR RIGHT LEG, RIGHT ARM, AND THE RIGHT SIDE OF THEIR BACK AND FACE DURING THEIR TRIAL PERIOD. THE PATIENT WAS INSTRUCTED TO TURN OFF THE DEVICE AND DISCONNECT THE TRANSMITTER ASSEMBLY WHICH RESOLVED THEIR SYMPTOMS. THE TRIAL DEVICE WAS PULLED AS EXPECTED AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Burning Sensation

  MAUDE report 19984302 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THE INCISION SITE. ANTIBIOTICS WERE PRESCRIBED AND THE NEUROSTIMULATOR WAS PULLED EARLY ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19822057 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED CRAMPING AND SWELLING IN THE BACK OF THEIR CALF. THE TRIAL NEUROSTIMULATOR WAS REMOVED AS SCHEDULED ON (B)(6) 2024. THE CLINICIAN PRESCRIBED A MUSCLE RELAXANT AND A STEROID PACK, AND THE CRAMPING AND SWELLING WENT DOWN 50%. THE SWELLING, REDNESS, AND CRAMPS ARE GONE. THE DOCTOR IS DISCUSSING OTHER OPTIONS (RETRIAL/IMPLANT/INTRATHECAL PUMP) FOR THE PATIENT.

  Patient problems: Cramp(s) /Muscle Spasm(s); Swelling/ Edema

  MAUDE report 19262466 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PUS OOZING FROM PREVIOUS INCISION WHILE CHANGING OUT BANDAGE. THE AREA WAS CLEANED, GAUZE WAS PLACED OVER IT, AND TAPED BACK DOWN. THE PATIENT FOLLOWED UP WITH THEIR CLINICIAN, ANTIBIOTICS WERE PRESCRIBED, AND THE LEAD WAS EXPLANTED ON (B)(6) 2024. THE INFECTION HEALED PROPERLY AND THE PATIENT WAS IMPLANTED WITH A PERMANENT NEUROSTIMULATOR ON (B)(6) 2024.

  Patient problems: Purulent Discharge

  MAUDE report 19262324 ↗
• InjuryApr 30, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED MILD, RANDOM ZAPPING SENSATIONS (NOT PAINFUL) THAT OCCURRED ON OCCASION SEVERAL DAYS INTO THE TRIAL. THEY TRAVELED THE DAY PRIOR AND REPORTS TSA PERFORMED AN AGGRESSIVE "PAT DOWN" OF AREA PRIOR TO THIS OCCURRING. THE PATIENT WAS INSTRUCTED TO POWER OFF THE DEVICE AND MEET WITH A LOCAL CLINICAL REPRESENTATIVE. THE TRANSMITTER SETTINGS WERE CHANGED (DECREASED) AND THE SENSATION HAS NOT OCCURRED AGAIN.

  Patient problems: Electric Shock

  MAUDE report 19218088 ↗
• InjuryMar 15, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT HAD A HEART ATTACK ON THE OR TABLE AFTER THE TRIAL PROCEDURE WAS COMPLETE. THE PATIENT WAS GIVEN NITROGLYCERIN, WAS MONITORED, AND AN AMBULANCE WAS CALLED DUE TO CONTINUED CHEST PAIN, LEFT ARM PAIN, AND NAUSEA. THE PATIENT WAS KEPT OVER NIGHT IN THE HOSPITAL AND A CARDIAC CATHETERIZATION WAS DONE. THEY ARE USING THE DEVICE, GETTING GREAT RELIEF IN THEIR KNEE, AND ARE DOING WELL AND ARE AT HOME. THE PATIENT IS PLANNING TO MOVE FORWARD WITH A PERMANENT IMPLANT PROCEDURE AFTER GETTING SIGNIFICANT RELIEF OF KNEE PAIN DURING TRIAL. THEY WILL FOLLOW UP WITH THEIR CARDIOLOGIST TO GET CLEARANCE BEFORE THE PERMANENT IMPLANT PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 18917674 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED INFLAMMATION AT THE INCISIONS WHEN THE LEADS WERE PULLED. THE CLINICAL REPRESENTATIVE DISCLOSED THE IRRITATION WAS CAUSED BY THE TAPE USED DURING THE TRIAL. THE PATIENT REPORTS FEELING MUCH BETTER SINCE THE LEADS WERE REMOVED AND NOT FEELING AS MUCH PAIN AS BEFORE THE TRIAL. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17643973 ↗

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-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-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-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-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-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