Freedom Spinal Cord Stimulator System FR8A-RCV-B0Recalls & reported problems

Stimwave Technologies Incorporated · Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel B US

All models of Freedom Spinal Cord Stimulator System (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859619004882), received between Aug 19, 2020 and Aug 19, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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

Device problems

Fracture1
Migration or Expulsion of Device1

Patient problems

Device Embedded In Tissue or Plaque1
Erosion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 19, 2020Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device
STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS SURROUNDING A COMPLAINT RESULTING FROM AN EXPLANT PROCEDURE WITH CLINICIAN AND THERAPY SPECIALIST ON (B)(6) 2017. THE STIMULATOR EXPLANT WAS SUCCESSFULLY COMPLETED, HOWEVER, THE DEVICE WAS LITERALLY "PULLED" APART DURING THE EXPLANT. HOWEVER, THIS EVENT DID NOT RESULT IN ANY INJURY TO THE PATIENT AND THEREFORE THE CLINICIAN AND SPECIALIST FILED THE OFFICIAL COMPLAINT IN THE SAME WEEK, BUT NOT ON THE DAY OF THE INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Erosion
MAUDE report 10424436 ↗

Device details

UDI-DI	`00859619004882`
Brand	Freedom Spinal Cord Stimulator System
Model	FR8A-RCV-B0
Catalog no.	S8R-1B US
Company	Stimwave Technologies Incorporated
Product code	—
Class	—
FDA submission	K150517
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Analgesic spinal cord electrical stimulation system

An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page