PNS Freedom-8A Permanent Neurostimulator Receiver Kit Channel A FR8A-RCV-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850051034284), received between Aug 12, 2025 and Apr 30, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THE RECEIVER SITE AND ANTIBIOTICS WERE PRESCRIBED. AS OF (B)(6) 2026, THE PATIENT IS DOING GREAT AND THE INFECTION HAS CLEARED UP. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25047564 ↗
• InjuryMar 17, 2026Use of Device Problem

  THE PATIENT REPORTED THEIR WOUNDS WERE NOT HEALING. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026. AS OF (B)(6) 2026, THE PATIENT IS DOING WELL. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Impaired Healing

  MAUDE report 24618690 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THE RECEIVER SITE. ADDITIONALLY, THE PATIENT REPORTED THE WOUND DID NOT HEAL PROPERLY. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026. AS OF (B)(6) 2026, THE PATIENT HAS HEALED.

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 24249213 ↗
• InjuryNov 20, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED A RED RASH WHICH SPREAD ACROSS THEIR BODY ABOUT TWO WEEKS AFTER THE NEUROSTIMULATOR WAS IMPLANTED. THE PATIENT WAS REFERRED TO A DERMATOLOGIST, ALLERGY TESTING WAS PERFORMED, AND AN ALLERGY TO PLATINUM IRIDIUM WAS FOUND. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025 WITHOUT ANY ISSUES.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23607459 ↗
• InjuryNov 10, 2025Off-Label Use; Off-Label Use

  THE PATIENT REPORTEDLY EXPERIENCED SWELLING IN THEIR FOREHEAD. HOWEVER, THE SWELLING WAS NOT VISIBLE AND THE LABS WERE NORMAL. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025. AS OF (B)(6) 2025 THE PATIENT IS EXPERIENCING SOME SWELLING ALTHOUGH IT HAS SOME IMPROVEMENT.

  Patient problems: Swelling/ Edema

  MAUDE report 23512591 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A SUPERFICIAL INFECTION AT THE RECEIVER SITE. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025. ONCE THE WOUND WAS OPENED, THERE WAS NO NOTICEABLE DISCHARGE OR REDNESS ASSOCIATED WITH THE SUPERFICIAL INFECTION. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Skin Infection

  MAUDE report 23027953 ↗
• InjuryAug 12, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED A ZAPPING SENSATION WHEN THE NEUROSTIMULATOR WAS NOT IN USE. THE COMMERCIAL TEAM MEMBER CHANGED THE PROGRAMS ON THE TRANSMITTER ASSEMBLY AND MOVED THE ELECTRODES WHICH RESOLVED THE REPORT OF ZAPPING SENSATIONS. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22790124 ↗

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-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-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-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