Resilience 55TRRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04035479170356), received between May 25, 2023 and May 4, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SEVERE NERVE PAIN IN THE LEFT ANKLE AND FOOT IMMEDIATELY AFTER THE PLACEMENT OF THE LEADS. SHE RATED IT AT 9/10 PAIN. THIS WAS NOT THE SITE OF HER ORIGINAL PAIN. AFTER ONE HOUR AND PAIN NOT RESPONDING TO MEDICATION THE PHYSICIAN DECIDED TO EXPLANT THIS LEAD. AT THIS POINT THE PAIN DID DECREASE. THE OTHER LEAD WAS ABLE TO REMAIN INTACT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Pain

  MAUDE report 25074681 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED A HEMATOMA THE SAME DAY THE LEADS WERE IMPLANTED. THE LEADS WERE EXPLANTED IN ORDER FOR PATIENT TO HAVE AN MRI.

  Patient problems: Hematoma

  MAUDE report 23518694 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED A HEMATOMA THE SAME DAY THE LEADS WERE IMPLANTED. THE LEADS WERE EXPLANTED IN ORDER FOR PATIENT TO HAVE AN MRI.

  Patient problems: Hematoma

  MAUDE report 23518693 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING NORMAL LEAD PULL, DOCTOR MENTIONED THE PATIENT HAVING A SUPERFICIAL INFECTION AND SENT HER HOME WITH ANTIBIOTICS. THE PATIENT RETURNED TO THE CLINIC COMPLAINING OF INCREASED HEADACHES AND BACKACHES. DOCTOR REFERRED HER TO THE HOSPITAL WHERE SHE WAS ADMITTED FOR AN INFECTION THAT COULD POTENTIALLY HAVE OCCURRED FROM HER RECENT SCS TRIAL. THE PHYSICIAN ALSO STATED THAT THE PATIENT RECEIVED A CT SCAN WITH THE FOLLOWING INFORMATION: LINEAR 5.8MM BONE ATTENUATING FOCI T12/L1 POTENTIAL FOREIGN BODY. THE LEADS DID NOT SHOW ANY DAMAGE WHEN REMOVED SO IT IS DOUBTFUL THE FOREIGN BODY IS FROM THEM.

  Patient problems: Unspecified Infection

  MAUDE report 22069760 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING NORMAL LEAD PULL, DOCTOR MENTIONED THE PATIENT HAVING A SUPERFICIAL INFECTION AND SENT HER HOME WITH ANTIBIOTICS. THE PATIENT RETURNED TO THE CLINIC COMPLAINING OF INCREASED HEADACHES AND BACKACHES. DOCTOR REFERRED HER TO THE HOSPITAL WHERE SHE WAS ADMITTED FOR AN INFECTION THAT COULD POTENTIALLY HAVE OCCURRED FROM HER RECENT SCS TRIAL. THE PHYSICIAN ALSO STATED THAT THE PATIENT RECEIVED A CT SCAN WITH THE FOLLOWING INFORMATION: LINEAR 5.8MM BONE ATTENUATING FOCI T12/L1 POTENTIAL FOREIGN BODY. THE LEADS DID NOT SHOW ANY DAMAGE WHEN REMOVED SO IT IS DOUBTFUL THE FOREIGN BODY IS FROM THEM.

  Patient problems: Unspecified Infection

  MAUDE report 22069758 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LEAD WAS EXPLANTED DUE TO EPIDURAL HEMATOMA CAUSING PT NAUSEA AND INCREASED PAIN. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Hematoma; Nausea; Pain

  MAUDE report 21925897 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LEAD WAS EXPLANTED DUE TO EPIDURAL HEMATOMA CAUSING PT NAUSEA AND INCREASED PAIN. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Hematoma; Nausea; Pain

  MAUDE report 21925895 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED TO HOSPITAL ONE DAY AFTER IMPLANT DUE TO A BLOOD CLOT IN HIS ARM. PATIENT UNDERWENT SURGERY FOR THE CLOT AND THE EPG SYSTEM WAS REMOVED AT THAT TIME. SHOULD FURTHER INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Embolism/Embolus

  MAUDE report 19752154 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED TO HOSPITAL ONE DAY AFTER IMPLANT DUE TO A BLOOD CLOT IN HIS ARM. PATIENT UNDERWENT SURGERY FOR THE CLOT AND THE EPG SYSTEM WAS REMOVED AT THAT TIME. SHOULD FURTHER INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Embolism/Embolus

  MAUDE report 19752151 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER TRIAL LEADS WERE PULLED, PATIENT STARTED HAVING INCREASED PAIN IN HIS REGULAR PAINFUL AREAS. PATIENT CONTRIBUTES HIS INCREASED PAIN TO THE PROCEDURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Pain

  MAUDE report 19359080 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER TRIAL LEADS WERE PULLED, PATIENT STARTED HAVING INCREASED PAIN IN HIS REGULAR PAINFUL AREAS. PATIENT CONTRIBUTES HIS INCREASED PAIN TO THE PROCEDURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Pain

  MAUDE report 19359078 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 18960644 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 18960636 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LEAD WAS EXPLANTED DUE TO PATIENT HAD HIGH LEVELS OF PAIN AT THE NEEDLE ENTRY SITE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Implant Pain

  MAUDE report 18455559 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LEAD WAS EXPLANTED DUE TO PATIENT HAD HIGH LEVELS OF PAIN AT THE NEEDLE ENTRY SITE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Implant Pain

  MAUDE report 18455242 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SEVERE PAIN UNDER EPG SITE. THE EPG AND LEADS WERE REMOVED ONE DAY PRIOR TO SCHEDULED TRIAL COMPLETION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Implant Pain

  MAUDE report 17850894 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SEVERE PAIN UNDER EPG SITE. THE EPG AND LEADS WERE REMOVED ONE DAY PRIOR TO SCHEDULED TRIAL COMPLETION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Implant Pain

  MAUDE report 17850889 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS REMOVED DUE TO SKIN IRRITATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17491660 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS REMOVED DUE TO SKIN IRRITATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17491659 ↗
• InjuryMay 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TRIAL SYSTEM WAS PUT INTO PLACE ON (B)(6) 2023. ON (B)(6) 2023 HIGH IMPEDANCES WERE SEEN. THE DEVICE HEADER WAS CHANGED OUT ON THAT DAY WITH NO CHANGE TO THE IMPEDANCES. DURING THE SCHEDULED LEAD PULL ON (B)(6) 2023 THIS LEAD WAS FOUND DISLODGED ALMOST COMPLETELY OUT OF THE BODY AND THE OTHER LEAD WAS COMPLETELY OUT OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007686 ↗
• MalfunctionMay 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TRIAL SYSTEM WAS PUT INTO PLACE ON (B)(6) 2023. ON (B)(6) 2023 HIGH IMPEDANCES WERE SEEN. THE DEVICE HEADER WAS CHANGED OUT ON THAT DAY WITH NO CHANGE TO THE IMPEDANCES. DURING THE SCHEDULED LEAD PULL ON (B)(6) 2023 THIS LEAD WAS FOUND DISLODGED ALL THE WAY OUT OF THE BODY AND THE OTHER WAS CLOSE TO COMPLETELY OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007608 ↗