StimQ Freedom-4A Trial Kit Channel A US w/ Receiver FR4A-TRL-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818225020716), received between Apr 21, 2021 and Jun 29, 2023 — classified as 8 injuries.

6 other recalls cover devices cleared under the same FDA submission (K171366); 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.

• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED UNINTENDED STIMULATION WHEN MOVING THEIR ARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Electric Shock

  MAUDE report 17233041 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THE LEAD FELL OUT OF THEIR WRIST WHILE THEY WERE SLEEPING. INFORMATION REGARDING THE PATIENT OUTCOME IS NOT AVAILABLE.

  Patient problems: Erosion

  MAUDE report 17195016 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEY FELT A CURRENT/SHOCK SENSATION DURING AN MRI. THE MRI WAS STOPPED IMMEDIATELY. THE DEVICE IS WORKING FINE SINCE THE INCIDENT.

  Patient problems: Electric Shock

  MAUDE report 17021939 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WENT TO THE ER DUE TO CONTINUOUS BLEEDING THE DAY AFTER THEIR IMPLANT PROCEDURE. ON (B)(6) 2023, WHEN THE ER STAFF REMOVED THE BANDAGE THE LEAD CAME OUT. THE PATIENT IS FINE AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16762825 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN ITCHING REACTION DURING THEIR TRIAL AND ASKED TO HAVE THE LEADS REMOVED EARLY. THEY WERE GIVEN CORTISONE CREAM TO TREAT THE AREA. THE PATIENT WAS ALSO COMPLAINING OF SEVERE RIGHT SIDED PAIN IN THEIR BACK AND LEG, WHICH THE DOCTOR SAID WAS RELATED TO THEIR L5-S1 HERNIATED DISC. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2023. THE PATIENT IS NO LONGER ITCHING AND THERE WAS NO INFECTION PRESENT.

  Patient problems: Itching Sensation; Pain

  MAUDE report 16501598 ↗
• InjuryFeb 20, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A SKIN REACTION AND THE TRIAL LEAD WAS REMOVED ON (B)(6) 2022. THE PATIENT'S SKIN WAS BURNING AND DEVELOPED EXTENSIVE BLISTERS. THE PATIENT IS DOING MUCH BETTER AND ALMOST COMPLETELY HEALED.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 13565460 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT IS HAVING DISCOMFORT RELATED TO THE LEAD EVEN WHEN STIMULATION IS TURNED OFF.

  Patient problems: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 12264336 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT ATTENDED A FOLLOW-UP APPOINTMENT WITH THE IMPLANTING CLINICIAN FOR A LEAD PULL FOR A SUSPECTED FOOT INFECTION.

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

  MAUDE report 11703701 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171366. 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-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-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-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