Resilience 55Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Resilience spinal cord stimulator is an implanted device that sends electrical pulses to ease pain. The 309 reports mostly describe systems being removed after pain relief fell short, with some reports of lead migration and infections. There are no deaths and 282 injuries reported, and no recalls name this device. Reports rose from 97 in the year before to 144 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 320
- Deaths reported
- 0
- Injuries reported
- 293
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 320 adverse event reports that list this exact device (DI 04035479170332), received between Jul 17, 2023 and Sep 30, 2026 — classified as 293 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (71 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem231
- Migration or Expulsion of Device71
- Impedance Problem5
- Positioning Problem5
- Device Dislodged or Dislocated4
- Defibrillation/Stimulation Problem2
- High impedance2
- Inappropriate/Inadequate Shock/Stimulation2
Patient problems
- Unspecified Infection105
- Inadequate Pain Relief100
- No Clinical Signs, Symptoms or Conditions60
- Implant Pain15
- Fall14
- Wound Dehiscence12
- Discomfort6
- Pain6
Recent adverse event reports
The 25 most recent of 320 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Migration or Expulsion of Device
Lead was explanted and replaced due to migration. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946287 ↗InjurySep 30, 2026Migration or Expulsion of Device
Lead was explanted and replaced due to migration. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945893 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
This system was explanted due to insufficient pain relief. Patient had a Pain pump implanted soon after SCS was implanted. Both devices were explanted as patient stated he felt that having both devices made him feel worse.
Patient problems: Inadequate Pain Relief
MAUDE report 50885894 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
This system was explanted due to insufficient pain relief. Patient had a Pain pump implanted soon after SCS was implanted. Both devices were explanted as patient stated he felt that having both devices made him feel worse.
Patient problems: Inadequate Pain Relief
MAUDE report 50885893 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
This system was explanted due to infection, date unknown. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50874114 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
This system was explanted due to infection, date unknown. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50874110 ↗InjurySep 15, 2026Migration or Expulsion of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782124 ↗InjurySep 15, 2026Migration or Expulsion of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781969 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50740073 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50740014 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50740013 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50740011 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
System explanted after several attempts of reprogramming both remotely and in person. Patient was not getting relief or coverage from and charging was becoming bothersome.
Patient problems: Inadequate Pain Relief
MAUDE report 50350996 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
This system was explanted due to patient not getting the relief that they got in the trial. Should additional information become available, this file will be updated.
Patient problems: Inadequate Pain Relief
MAUDE report 50234866 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to patient discomfort. Should additional information be received, this file will be updated.
Patient problems: Discomfort
MAUDE report 50162608 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD LOSS OF THERAPY, IN ADDITION TO A NEW CERVICAL PAIN PATTERN. LEAD EXPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Inadequate Pain Relief; Pelvic Pain
MAUDE report 25695849 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INADEQUATE PAIN RELIEF. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Inadequate Pain Relief
MAUDE report 25691430 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INADEQUATE PAIN RELIEF. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Inadequate Pain Relief
MAUDE report 25691429 ↗InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INADEQUATE PAIN RELIEF AND PATIENT COMPLAINT OF DISCOMFORT AT IPG SITE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort; Inadequate Pain Relief
MAUDE report 25661695 ↗InjuryJun 29, 2026Migration or Expulsion of Device
THIS LEAD WAS EXPLANTED DUE TO MIGRATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25661694 ↗InjuryJun 29, 2026Migration or Expulsion of Device
THIS LEAD WAS EXPLANTED DUE TO MIGRATION FOLLOWING PATIENT FALL. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Fall
MAUDE report 25651645 ↗InjuryJun 17, 2026Adverse 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 25537994 ↗InjuryJun 17, 2026Adverse 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 25537993 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INADEQUATE PAIN RELIEF. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Inadequate Pain Relief
MAUDE report 25533714 ↗InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INADEQUATE PAIN RELIEF. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Inadequate Pain Relief
MAUDE report 25502674 ↗
Other Stimulator, spinal-cord, totally implanted for pain relief devices
- Octrode™ 3186St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF30 deaths32,096 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- RestoreSensor™SureScan® 97714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 deaths17,903 reports
- Proclaim™ 3660St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls25 deaths13,336 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
- Proclaim™ 5 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall10 deaths9,661 reports
- Proclaim™ 7 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall12 deaths7,299 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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