PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A STQ4-RCV-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 364 adverse event reports that list this exact device (DI 00850051034406), received between Jul 17, 2023 and Sep 29, 2026 — classified as 8 deaths, 356 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (174 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 364 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported a stitch was eroding from the implant site. The patient went to the hospital due to pain at the suture site and was given guidance on how to move forward with imaging. On (b)(6) 2026, X-Rays were performed, migration was not suspected, and it was noted the patient did not have stiches poking through their skin. However, the patient had bulging at the pocket site where the coils and stitches were. A revision procedure was performed where the physician buried the stitches and coil deeper under the skin to reduce patient discomfort. No further issues have been reported.

  Patient problems: Pain

  MAUDE report 50937584 ↗
• InjurySep 29, 2026Use of Device Problem

  The patient reported their incision re-opened and was now infected. Antibiotics were prescribed and an explant procedure was performed on (b)(6) 2026.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 50936648 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  The patient was taken to the hospital on (b)(6) 2026 due to swelling in the lower extremity and concerns of infection. Antibiotics were prescribed the week prior after a follow up appointment with the implanting clinician. As of (b)(6) 2026, the patient completed their antibiotics, they are doing well, and resumed using the neurostimulator without issue.

  Patient problems: Swelling/ Edema

  MAUDE report 50886588 ↗
• InjurySep 24, 2026Use of Device Problem

  The patient reported an infection at the receiver site with clear liquid discharge off and on. Antibiotics were prescribed and an explant procedure was approved. Several attempts have been made to schedule the explant procedure. However, the patient refuses to move forward and does not want to take the device out. The physician is planning to speak to the patient again. No further information is available at this time.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 50885184 ↗
• InjurySep 17, 2026Use of Device Problem

  Patient problems: Impaired Healing

  MAUDE report 50809527 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported their distal incision at the receiver site was opening and started to show signs of infection with redness, pus, and odor. Antibiotics were prescribed and an incision washout was performed on (b)(6) 2026. As of (b)(6) 2026, the patient is fine. No further information is available at this time.

  Patient problems: Post Operative Wound Infection; Purulent Discharge; Wound Dehiscence; Wound Odor

  MAUDE report 50804957 ↗
• InjurySep 10, 2026Use of Device Problem

  Patient problems: Erosion

  MAUDE report 50721125 ↗
• DeathSep 10, 2026Adverse Event Without Identified Device or Use Problem

  Curonix Support was notified the patient had passed on (b)(6) 2026 from non-device related factors. There were no alleged deficiencies, therapy was working properly, and the family would be returning the Transmitter Assemblies.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718039 ↗
• InjurySep 10, 2026Use of Device Problem

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 50717506 ↗
• InjurySep 8, 2026Use of Device Problem

  Patient problems: Cellulitis

  MAUDE report 50676335 ↗
• InjurySep 8, 2026Use of Device Problem

  The patient reported blisters between each incision on both of their legs. The patient stopped using the device and the implanting clinician is considering sending the patient to an allergist to test for allergies to implant materials. As of (b)(6) 2026, there are no new updates or information at this time.

  Patient problems: Blister

  MAUDE report 50673949 ↗
• InjurySep 8, 2026Use of Device Problem

  The patient reported erosion and an explant procedure was performed on (b)(6) 2026. No further issues have been reported.

  Patient problems: Erosion

  MAUDE report 50671501 ↗
• InjuryAug 20, 2026Use of Device Problem

  The patient reported periodic uncomfortable stimulation. The frequency was lowered on the Transmitter Assemblies and as of (b)(6) 2026, the shocking sensations have gone away and the patient is getting marginal relief.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50356236 ↗
• InjuryAug 3, 2026Use of Device Problem

  Patient problems: Impaired Healing

  MAUDE report 50116577 ↗
• InjuryJul 31, 2026Migration

  The patient reported "something" was sticking out of their leg, bruising, as well as the incision not fully closing. The patient was seen on (b)(6) 2026 and it was noted a suture had eroded on both sides of the incision site. However, there were no signs of infection. Additionally, X-Rays were performed which confirmed device migration of the right neurostimulator. The protruding sutures were clipped and a follow-up was scheduled for additional monitoring. Additional information was provided. The bruising had resolved and an explant procedure was performed on (b)(6) 2026. No further issues have been reported.

  Patient problems: Bruise/Contusion; Impaired Healing

  MAUDE report 50107358 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  The patient experienced severe itching and drainage from the incision sites. Antibiotics were prescribed, the patient has seen wound care, the itchiness was clearing, the wound was wrapped, and the patient was instructed not to resume therapy until the wounds were completely healed. Additional information was received on July 29, 2026. Although the wounds healed under wound care, the itchiness and drainage continued and the wound opened back up. An explant procedure will be performed. However, a date has not yet been scheduled. No further information is available at this time.

  Patient problems: Fluid Discharge; Itching Sensation

  MAUDE report 50105628 ↗
• 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 50093836 ↗
• InjuryJul 29, 2026Use of Device Problem

  The reported an infection in their left shoulder, that moved into their prosthetic shoulder joint. Antibiotics were prescribed and an explant procedure was performed on (b)(6)2026. As of (b)(6) 2026, the patient is recovering from the explant procedure. No further issues have been reported.

  Patient problems: Medical device site infection

  MAUDE report 50077587 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported their receiver site had not healed. Cultures were obtained. However, an infection was not confirmed. The patient has been going to wound care for three months where they have been monitoring, debriding, and dressing the wound. Additionally, the patient completed a short term steroid to improve healing. As of (b)(6) 2026, the incision has improved significantly since their previous visit and the wound has reduced in size greater than 50%. The patient will follow up with wound clinic, they are using their device and getting great relief. No further issues have been reported.

  Patient problems: Impaired Healing

  MAUDE report 50076670 ↗
• InjuryJul 29, 2026Use of Device Problem

  The patient reported increased pain in their lower leg and no longer receiving pain relief. On (b)(6) 2026, the Commercial Team Member met with the patient and re-educated them on where to place the Transmitter Assembly Antenna to receive adequate therapy. Additionally, the power index was decreased on the Transmitter Assembly. Therapy has been restored and the pain resolved. The patient will follow-up with the Commercial Team Member to see how therapy is going.

  Patient problems: Pain

  MAUDE report 50074049 ↗
• DeathJul 2, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE COMMERCIAL TEAM MEMBER WAS NOTIFIED THE PATIENT PASSED AWAY. HOWEVER, THE SPECIFIC DATE OF THE PASSING IS UNKNOWN. THE HOSPITAL HAS EXPLICITLY CONFIRMED THAT THIS DEATH WAS NOT RELATED TO THE CURONIX SYSTEM AND THERE WERE NO ALLEGED DEFICIENCIES ASSOCIATED WITH THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25697814 ↗
• InjuryJun 30, 2026Use of Device Problem

  THE PATIENT REPORTED EROSION OF THE NEUROSTIMULATOR. ON (B)(6) 2026, A REVISION PROCEDURE WAS PERFORMED WHERE THE PHYSICIAN RE-SUTURED THE NEUROSTIMULATOR TO THE FASCIA. ANTIBIOTICS WERE GIVEN DURING THE REVISION PROCEDURE. THE PATIENT ATTENDED A FOLLOW-UP APPOINTMENT ON (B)(6) 2026, WHERE THE STAPLES WERE REMOVED. ADDITIONALLY, THE PATIENT REPORTED THEY NO LONGER HAVE THE BAD ITCHING FROM THE EROSION, AND THEY ARE DOING WELL. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Erosion

  MAUDE report 25668291 ↗
• InjuryJun 29, 2026Use of Device Problem

  THE PATIENT REPORTED AN INFECTION IN THEIR LEFT LOWER LEG. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026, I.V. ANTIBIOTICS WERE PRESCRIBED, AND THE PATIENT STAYED IN THE HOSPITAL FOR SEVERAL DAYS FOR OBSERVATION. HOWEVER, THE DATES OF THE HOSPITAL OBSERVATION AND SERIAL NUMBER OF THE DEVICE THAT WAS EXPLANTED ARE UNKNOWN. THE PATIENT IS DOING BETTER, CURRENTLY TAKING ORAL ANTIBIOTICS, WEARING A WOUND VAC, AND THE WOUND VAC DRESSING IS BEING CHANGED EVERY FEW DAYS. THE COMMERCIAL TEAM MEMBER HAS MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT FOR FURTHER INFORMATION WITHOUT SUCCESS.

  Patient problems: Skin Infection

  MAUDE report 25659393 ↗
• InjuryJun 24, 2026Migration

  THE PATIENT REPORTED LOSS OF THERAPY AND PAIN FROM THE NEUROSTIMULATORS POKING THEM UNDER THE SKIN. SEVERAL ATTEMPTS HAVE BEEN MADE TO CHANGE THE PROGRAMS ON THE TRANSMITTER ASSEMBLY WITHOUT SUCCESS. HOWEVER, X-RAYS CONFIRMED DEVICE MIGRATION. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 25616395 ↗
• InjuryJun 24, 2026Off-Label Use

  THE PATIENT REPORTED MANY INSTANCES OF "SHOCKS" IN THEIR CHEEK WHILE WEARING THE DEVICE. THE PATIENT WAS ADVISED TO STOP USING THE DEVICE UNTIL THE PROGRAMS ON THE TRANSMITTER ASSEMBLY COULD BE CHANGED. ON (B)(6) 2026, THE PROGRAMS ON THE TRANSMITTER ASSEMBLY WERE LOWERED, THE PATIENT WAS GIVEN A PRESCRIPTION OF LIDOCAINE SPRAY AND PATCHES, AND THE PATIENT WAS ASKED TO NOT USE THEIR DEVICES. THE PATIENT WILL TRY THE NEW PROGRAMS ON THE TRANSMITTER ASSEMBLY WHEN THEY RETURN FROM A THREE-WEEK HOLIDAY AND THEIR POST-OPERATIVE PAIN HAS SUBSIDED. THE PATIENT WILL FOLLOW-UP WITH THE HOSPITAL OUTPATIENT CLINIC. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25613357 ↗

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-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-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-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