StimQ Freedom-8A Trial Kit Channel B US w/ Receiver FR8A-TRL-B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818225020785), received between May 9, 2023 and Jul 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2023Migration; Migration

  THE PATIENT REPORTED FEELING NO THERAPY AND STIMULATION AND DISCOMFORT IN THE GROIN AREA DURING SUPERIOR CLONAL PLACEMENT. ADDITIONALLY, MIGRATION WAS CONFIRMED VIA X-RAY. AN EXPLANT PROCEDURE WAS PERFORMED (B)(6) 2023. REMOVING THE LEAD AND TURNING OFF THE TRANSMITTER RESOLVED THE STIMULATION. HOWEVER, AFTER THE EXPLANT, THE PATIENT DECIDED NOT TO MOVE FORWARD WITH A RE-TRIAL. THE PHYSICIAN IS WORKING WITH THE PATIENT ON AN ALTERNATIVE TREATMENT OPTION.

  Patient problems: Pain

  MAUDE report 17293305 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED BLEEDING FROM THE MOUTH FOLLOWING A TRIAL PROCEDURE. THE PATIENT COMPLETED THE TRIAL, AND THE LEADS WERE PULLED ON (B)(6) 2023. THE PATIENT IS CURRENTLY DOING WELL AND IS AWAITING THEIR PERMANENT IMPLANT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16896731 ↗

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-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-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-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-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