StimQ Freedom-8A Trial Kit Channel A US w/ Receiver FR8A-TRL-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818225020792), received between Feb 11, 2019 and Jul 11, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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.

• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PAIN AFTER BENDING OVER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 17302152 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN ACHY BURNING FEELING IN THEIR BUTTOCK WHICH STARTED DURING THE PROCEDURE. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WAS NO LONGER GETTING A BURNING PAIN IN THEIR BUTTOCK.

  Patient problems: Electric Shock

  MAUDE report 17301370 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THE TRIAL LEAD PULL. THE DRESSING APPEARED TO HAVE BEEN DISPLACED AND THE PATIENT'S MOTHER PUT BANDAIDS OVER THE WOUNDS. ANTIBIOTICS WERE PRESCRIBED AND THE WOUND HAS FULLY HEALED. THE PATIENT GOT GOOD RELIEF DURING THE TRIAL AND WANTS TO MOVE FORWARD WITH A PERMANENT IMPLANT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16273417 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SWELLING, PAIN, AND TENDERNESS AT THE INCISION SITE. THE TRIAL LEAD WAS EXPLANTED ON (B)(6) 2022 PRIOR TO THE SCHEDULED REMOVAL. ANTIBIOTICS WERE PRESCRIBED POSTOPERATIVELY HOWEVER THE PATIENT DID NOT TAKE THEM. THE PATIENT IS DOING BETTER AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 13933309 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THE SKIN ENTRY SITE WAS RED, RAISED, PAINFUL, AND HAD BLISTERS AFTER THE LEAD PULL. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2022. THE PATIENT IS DOING BETTER AND THE WOUND IS HEALING AFTER A SECOND ROUND OF ANTIBIOTICS. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Blister; Erythema; Pain; Skin Infection

  MAUDE report 13527889 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PAIN AND TENDERNESS AT THE INCISION SITE. IT APPEARED PART OF THE TEGADERM HAD PEALED UP, LEAVING THE TAIL END OF THE LEAD EXPOSED. THE PHYSICIAN NOTED THE INCISION SITE WAS RED, SWOLLEN AND HAD PUS AS WELL. BECAUSE IT LOOKED LIKE THE BEGINNING OF AN INFECTION, ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT WAS PERFORMED ON (B)(6) 2021. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Erythema; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 12856110 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS SURROUNDING A COMPLAINT RESULTING FROM AN UNCONFIRMED INFECTION THAT OCCURRED IN (B)(6) REPORTED TO STIMWAVE ON MAY 7, 2019, BY STIMWAVE TERRITORY MANAGER.

  Patient problems: Unspecified Infection

  MAUDE report 10424434 ↗
• InjuryFeb 11, 2019Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE CLINICAL SPECIALIST WAS MADE AWARE THAT A PATIENT'S STIMULATOR HAD ERODED THROUGH HIS SKIN WHILE ATTENDED AN APPOINTMENT WITH THE PATIENT AND THE IMPLANTING CLINICIAN. DURING THIS APPOINTMENT, THE PATIENT REPORTED THAT HE HAD NOTICED THE DEVICE PLACED ABOVE HIS EYE PROTRUDING THROUGH HIS SKIN SLIGHTLY, BUT THE WOUND WAS SLIGHTLY REDDENED BUT NOT INFLAMED, OR BLEEDING. THE PATIENT RECOUNTED THAT HE CONTACTED THE IMPLANTING CLINICIAN REGARDING THE ISSUE. THE CLINICAL SPECIALIST WAS NOT AWARE OF THIS COMMUNICATIONS BETWEEN THE IMPLANTING CLINICIAN AND THE PATIENT UNTIL (B)(6) 2019. THE IMPLANTING CLINICIAN EVALUATED THE DEVICE EROSION AND DID NOT OBSERVE ANY SIGNS OF INFECTION. HE ALSO VERIFIED THAT THE OTHER TWO DEVICES HAD NEITHER MIGRATED NOR PRESENTED ANY EVIDENCE OF DEVICE EROSION. THE IMPLANTING CLINICIAN RECOMMENDED THAT THE DEVICE BE REVISED. ON (B)(6) 2019, THE IMPLANTING CLINICIAN REVISED THE STIMULATOR WITHOUT COMPLICATION. TO PREVENT DEVICE EROSION IN THE FUTURE, THE CLINICIAN DID NOT ADVANCE THE DEVICE AS FAR MEDIAL, AS THE AREA OVER THE PATIENT'S RIGHT EYE WAS NOT AS MUSCULAR, AND THE SKIN WAS THIN. THE PATIENT DID NOT REPORT ANY ISSUES AND IS CONTINU

  Patient problems: Skin Erosion

  MAUDE report 8329718 ↗

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-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-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-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
• 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