Resilience 75TRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04035479170349), received between May 29, 2024 and May 12, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  LEAD WAS ATTEMPTED BUT NOT IMPLANTED. PROCEDURE WAS ABORTED. PATIENTS BLOOD PRESSURE FELL BELOW 90/40. MD TOOK NEEDLES AND LEADS OUT AND FLIPPED THE PATIENT OVER. EMERGENT SITUATION WHICH WAS RESOLVED AFTER FLIPPING THE PATIENT OVER.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25148744 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  LEAD WAS ATTEMPTED BUT NOT IMPLANTED. PROCEDURE WAS ABORTED. PATIENTS BLOOD PRESSURE FELL BELOW 90/40. MD TOOK NEEDLES AND LEADS OUT AND FLIPPED THE PATIENT OVER. EMERGENT SITUATION WHICH WAS RESOLVED AFTER FLIPPING THE PATIENT OVER.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25148743 ↗
• MalfunctionApr 23, 2026Break

  LEAD ATTEMPTED BUT NOT IMPLANTED. MD WAS ATTEMPTING TO PLACE LEAD AT LEVEL T5-6 WHERE NEEDLE WAS PLACED WHEN THE LEAD SEEMED TO HAVE GOTTEN IMPACTED BY THE LIGAMENT THEN THE PHYSICIAN ATTEMPTED TO REMOVE THE NEEDLE AND THE LEAD. ONE CONTACT OF THE LEAD REMAINED IN THE PATIENT EPIDURAL SPACE IN THE T5 AREA WHILE THE REMAINING LEAD AND NEEDLE WERE REMOVED. NO COMPLICATION OCCURRED DUE TO THIS INCIDENT. THERAPY WAS ACTIVATED WITH GOOD PAIN RELIEF AS TRIAL CONTINUES. PATIENT WILL BE SENT TO NEUROSURGERY FOR REMOVAL OF THE BROKEN CONTACT WHEN THE PERMANENT SYSTEM IS IMPLANTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24967127 ↗
• MalfunctionMay 29, 2024Fracture; Fracture

  TRAUMA WAS CAUSED TO THE LEAD WHEN THE PHYSICIAN WAS TRYING TO ADVANCE THE NEEDLE INTO THE EPIDURAL SPACE WHILE THE LEAD WAS PARTIALLY ADVANCED BEYOND THE NEEDLE TIP. ELECTRODE 1 AND 2 BROKE OFF THE LEAD WHILE THE PHYSICIAN WAS REMOVING THE LEAD AND NEEDLE. THE TWO ELECTRODES ARE OUTSIDE THE EPIDURAL SPACE AND THE PHYSICIAN PLANS ON REMOVING THEM WHEN THE PATIENT HAS THE PERMANENT IMPLANT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19416741 ↗