PNS Freedom-8A Trial Neurostimulator Kit Channel B FR8A-TRL-B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850051034390), received between Mar 6, 2024 and Mar 2, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Use of Device Problem

  THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AFTER EXPERIENCING HEADACHE AND NECK PAIN, WHICH RAISED CONCERN FOR POSSIBLE MENINGITIS. CULTURES WERE OBTAINED. HOWEVER, NO GROWTH WAS OBSERVED ON CULTURES AND AN INFECTION WAS NOT CONFIRMED. THE PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2026, ANTIBIOTICS WERE PRESCRIBED PROPHYLACTICALLY, AND THE DEVICES WERE PULLED EARLY ON (B)(6) 2026. AS OF ON (B)(6) 2026, THE PATIENT IS STABLE AND AT HOME.

  Patient problems: Headache; Neck Pain

  MAUDE report 24490858 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED HIGH BLOOD PRESSURE AND NAUSEA AFTER THEIR TRIAL PROCEDURE. THE PATIENT WAS TAKEN TO THE HOSPITAL ON (B)(6) 2025, AND WAS RELEASED LATER THAT DAY. HOWEVER, THE PATIENT WENT TO THE HOSPITAL ON FOUR SEPARATE OCCASIONS SINCE THEN AND WAS ADMITTED ON (B)(6) 2025 FOR SEVERE STOMACH PAIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE TRIAL NEUROSTIMULATOR WAS REMOVED. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: High Blood Pressure/ Hypertension; Nausea

  MAUDE report 23959899 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED NUMBNESS, TINGLING, AND WEAKNESS IN THEIR LEGS DURING THEIR TRIAL. THE TRIAL DEVICES WERE PULLED AND THE PHYSICIAN DOES NOT RELATE THE PATIENT'S SYMPTOMS TO THE CURONIX DEVICES.

  Patient problems: Muscle Weakness/Atrophy; Numbness

  MAUDE report 22978962 ↗
• InjuryJul 24, 2024Migration; Migration

  THE PATIENT REPORTED BLEEDING AND SWELLING AT THE INCISION SITE AS WELL AS SEVERE PAIN. ON (B)(6) 2024, THE PATIENT WENT TO THE ER, MIGRATION WAS CONFIRMED VIA X-RAY, AND THE DEVICE WAS REMOVED. THE PATIENT IS DOING FINE AND IS NOT EXPERIENCING ANY MORE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 19822049 ↗
• InjuryMar 6, 2024Migration; Migration

  THE PATIENT REPORTED LOSS OF THERAPY AND WAS CONCERNED WITH BLOOD ON THEIR BACK. THE PATIENT RETURNED TO THE OFFICE FOR REPROGRAMMING AND TROUBLESHOOTING. HOWEVER, WHEN THE DRESSING WAS INSPECTED, THERE WAS QUITE A BIT OF RED FLUID UNDER OCCLUSIVE DRESSING, AND THE LEAD PLACEMENT COULD NOT BE VISUALLY VERIFIED. THE OFFICE STAFF TOOK AN X-RAY AND CONFIRMED THAT THE LEADS MIGRATED. THE IMPLANTING PHYSICIAN ELECTED TO PULL THE LEADS ON (B)(6) 2024, AND DISCONTINUE THE TRIAL. ONCE REMOVED, THERE WAS NO ACTIVE BLEEDING NOTED. THE PATIENT WAS GOING TO SEE THE DOCTOR FOR OTHER PAIN MANAGEMENT OPTIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18844375 ↗

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-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-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-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-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