Freedom Spinal Cord Stimulator System FR8A-TRL-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859619004912), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 injury.

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

• InjuryMar 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS FROM A MEDWATCH REPORT (MW5074879) SUBMITTED BY A PATIENT (B)(6) 2018. STIMWAVE BECAME AWARE OF THE EVENT ON (B)(6) 2018 FOLLOWING RECEIPT OF THE REPORT (DATED (B)(6) 2018) BY THE (B)(6). THE FOLLOWING EVENT DESCRIPTION WAS PROVIDED IN THE MEDWATCH REPORT: ON (B)(6) 2017, I HAD A STIMWAVE SYSTEM IMPLANTED IN (B)(6). IT ONLY WORKED FOR ABOUT 2 WEEKS AND THEN STOPPED PROVIDING PAIN RELIEF. I TRIED CALLED THE CORPORATE HEADQUARTERS SEVERAL TIMES, BUT GOT NO RESPONSE. ON (B)(6) 2018, A RED SPOT DEVELOPED ON MY SKIN ON MY BACK AND A WIRE WAS VISIBLE. I HAD A FAMILY MEMBER PULL IT OUT AND CONTACTED A COMPANY ENGINEER TO INFORM OF THE PROBLEM. I HAVE BEEN INFORMED BY MY PHYSICIAN TO EXPLANT THE SYSTEM AS A SPINAL CORD INFECTION MIGHT DEVELOPE (SIC). MY PROCEDURE WAS SCHEDULED FOR ME DUE TO THE URGENCY OF THE MATTER.

  Patient problems: Missing Value Reason; No Information

  MAUDE report 7323927 ↗