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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818225020662), received between May 15, 2019 and Apr 28, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED REDNESS, PUS AND BURNING AT THE SURGICAL SITE. INFECTION WAS CONFIRMED, A CLEAN DRESSING WAS APPLIED AND ANTIBIOTICS WERE PRESCRIBED. THE LEADS WERE REMOVED ON (B)(6) 2023. THE PATIENT IS CURRENTLY DOING WELL AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Burning Sensation; Purulent Discharge; Skin Infection

  MAUDE report 16840104 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THE PATIENT WAS IMPLANTED WITH A TRIAL SPINAL CORD NERVE STIMULATOR IN THE EPIDURAL SPACE. ON (B)(6) 2022 THE PATIENT REPORTED SWELLING IN THEIR LEFT FOOT. ANTIBIOTICS WERE PRESCRIBED ALTHOUGH AN INFECTION WAS NOT CONFIRMED. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2022, AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 14501500 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE TERRITORY MANAGER WAS MADE AWARE BY THE PATIENT THAT HE HAD SCRATCHED THROUGH THE LAYERS OF TEGADERM CONCEALING HIS TRIAL STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM AND IN THE PROCESS, HAD DISLODGED THE DEVICE IMPLANTED IN HIS LEFT LEG, NEARLY PULLING IT OUT COMPLETELY. THE TERRITORY MANAGER IMMEDIATELY CONTACTED THE IMPLANTING CLINICIAN AND HE INSTRUCTED THE PATIENT TO COMPLETELY REMOVE THE DEVICE FROM HIS LEFT LEG, COVER THE WOUND SITE WITH OVER-THE-COUNTER ANTIBIOTIC OINTMENT AND A BANDAGE AND RETURN TO THE CLINIC ON (B)(6) 2019 FOR EVALUATION AND REMOVAL OF THE OTHER TRIAL DEVICE. ON (B)(6) 2019, THE IMPLANTING CLINICIAN REMOVED THE TRIAL DEVICE IMPLANTED IN THE PATIENT'S RIGHT LEG AND NOTED NO ISSUES WITH THAT WOUND SITE. UPON EVALUATION OF THE LEFT LEG, THE IMPLANTING CLINICIAN OBSERVED THAT THE SKIN WAS RED AND INFLAMED AND THE PATIENT PRESENTED WITH A LOW-GRADE FEVER. THE IMPLANTING CLINICIAN INSTRUCTED THE PATIENT TO SEEK TREATMENT AT AN EMERGENCY ROOM. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS (VANCOMYCIN) AT A LOCAL HOSPITAL, AND RELEASED THE SAME DAY WITH A PRESCRIPTION OF ORAL ANTIBIOTICS (NAME, DOSE, AND DURATION IS UNKNOWN). ON

  Patient problems: Cellulitis; Post Operative Wound Infection

  MAUDE report 8614047 ↗