PNS Freedom-4A Trial Neurostimulator Kit Channel B FR4A-TRL-B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00850051034383), received between Nov 1, 2023 and Mar 30, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Use of Device Problem

  THE PATIENT WAS TOLD THEY HAD AN INFECTION AT THEIR TRIAL PULL APPOINTMENT. ADDITIONALLY, THE PATIENT EXPERIENCED SOME SWELLING. ANTIBIOTICS WERE PRESCRIBED AND THE TRIAL NEUROSTIMULATOR WAS PULLED ON THE PLANNED DATE OF (B)(6), 2026. AS OF MARCH 16, 2026, THE PATIENT COMPLETED ALL OF THEIR ANTIBIOTICS AND THE SWELLING HAS REDUCED. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 24735732 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THE INCISION SITE. ADDITIONALLY, THE PATIENT REPORTED THEIR LEG WAS SWOLLEN, PAINFUL, RED, AND WARM. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2026 AND THE TRIAL NEUROSTIMULATOR WAS PULLED EARLY. ANTIBIOTICS WERE PRESCRIBED, AND AS OF (B)(6) 2026, THE INFECTION HAS CLEARED UP AND THE PATIENT IS DOING FINE.

  Patient problems: Pain; Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 24249215 ↗
• InjuryJul 21, 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. THE TRIAL WAS SUCCESSFUL WITH >80% PAIN RELIEF AND THE TRIAL WAS PULLED AS EXPECTED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED THEIR KNEE WAS HOT AND IN CONSTANT PAIN. THE PATIENT WAS INSTRUCTED TO REACH OUT TO THEIR DOCTOR TO DISCUSS THEIR CONCERNS. AS ON (B)(6) 2025, THERE IS NO INDICATION OF ISSUES AND THE PATIENT IS SCHEDULED FOR A PERMANENT IMPLANT PROCEDURE ON (B)(6) 2025.

  Patient problems: Pain

  MAUDE report 22560593 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SEVERE LOW BACK PAIN WITH RADICULAR/SCIATIC SYMPTOMS BURNING TO THEIR FOOT. ADDITIONALLY, THE PATIENT HAS A HISTORY OF DEPRESSION AND REPORTED SIGNIFICANT MOOD ALTERATION. THE PATIENT FOLLOWED UP WITH THEIR PRIMARY CARE PHYSICIAN REGARDING THE MOOD CHANGES AND COMPLETED THE TRIAL. ALTHOUGH THE PATIENT REPORTED 40% PAIN RELIEF FROM THE TRIAL, THEY DID NOT HAVE ANY FUNCTIONAL IMPROVEMENTS IN THEIR ABILITY TO STAND OR WALK LONGER SO THEY WILL NOT MOVE TO PERMANENT IMPLANT. AS OF (B)(6) 2025, THE BACK AND RADICULAR PAIN RESOLVED AND THE PATIENT IS BEING TREATED FOR MOOD DISORDERS/DEPRESSION BY THEIR PRIMARY CARE PHYSICIAN.

  Patient problems: Pain

  MAUDE report 21964256 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TRIAL PATIENT REPORTED POST-OPERATIVE PAIN AND THE NEUROSTIMULATORS WERE PULLED EARLY ON (B)(6) 2024. THE COMMERCIAL TEAM MEMBER EXPLAINED THAT THE POST-OPERATIVE PAIN THE PATIENT WAS EXPERIENCING WAS NORMAL. AFTER THE NEUROSTIMULATORS WERE PULLED, THE PATIENT COMPLAINED OF PAIN AROUND THEIR RIBS. THE PHYSICIAN DOES NOT BELIEVE THE PAIN IS RELATED TO THE DEVICE AS THE PAIN IS NOT OCCURRING IN THE IMPLANTED AREA. AS OF ON (B)(6) 2024, THE PATIENT IS DOING WELL.

  Patient problems: Pain

  MAUDE report 20605592 ↗
• InjuryMay 20, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED SHARP PAIN, LEG SWELLING, AND SORENESS AT THE INCISION SITE. THE COMMERCIAL TEAM MEMBER OFFERED REPROGRAMMING. HOWEVER, THE PATIENT DECLINED REPROGRAMMING AND REQUESTED TO REMOVE THE NEUROSTIMULATOR. THE NEUROSTIMULATOR WAS PULLED ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19354945 ↗
• InjuryApr 5, 2024Use of Device Problem; Use of Device Problem

  THE COMMERCIAL TEAM MEMBER REPORTED THAT THE IMPLANTING CLINICIAN WAS UNABLE TO SAFELY ADVANCE THE INTRODUCER TO IMPLANT THE TRIAL NEUROSTIMULATOR WITHOUT MOVING/DRAGGING SURROUNDING TISSUE WITH IT. THE TRIAL PROCEDURE WAS ABORTED. THE PATIENT RECEIVED A NERVE BLOCK AND WILL SEARCH FOR OTHER PAIN RELIEF OPTIONS.

  Patient problems: Insufficient Information

  MAUDE report 19056388 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED ITCHINESS, IRRITATION, AND REDNESS FROM THE TAPE USED TO SECURE THE TRIAL LEAD. THE TRIAL LEAD PULL WAS PERFORMED ON (B)(6) 2023 AND THE PATIENT WILL NOT BE MOVING FORWARD WITH A PERMANENT IMPLANT. THE COMMERCIAL TEAM MEMBER ATTEMPTED TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18049480 ↗

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-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-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-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-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-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