Resilience 75Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
All models of Resilience (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Resilience 75 is an implanted spinal cord stimulator used for pain relief. The 70 reports mostly describe leads shifting out of position, infection at the incision site, and pain relief that was not enough, with several systems removed or revised. There are 63 injuries and no deaths. No recalls name this device, and reports in the last 12 months (32) are nearly double the17 in the previous 12 months.
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
- 72
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 04035479170325), received between Oct 3, 2023 and Sep 17, 2026 — classified as 65 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem55
- Migration or Expulsion of Device13
- Insufficient Device Problem Information2
- Activation, Positioning or Separation Problem1
- Device Dislodged or Dislocated1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- Unspecified Infection30
- Inadequate Pain Relief26
- No Clinical Signs, Symptoms or Conditions10
- Implant Pain3
- Limb Pain2
- Muscle Weakness/Atrophy2
- Wound Dehiscence2
- Discomfort1
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
This system was explanted due to loss of therapy. Should additional information become available, this file will be updated.
Patient problems: Inadequate Pain Relief
MAUDE report 50804720 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
This system was explanted due to loss of therapy. Should additional information become available, this file will be updated.
Patient problems: Inadequate Pain Relief
MAUDE report 50804650 ↗InjuryJun 22, 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 25587954 ↗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 25533631 ↗InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
PATIENT IS DRAINING CLEAR FLUID AT INCISION SITES. DURING REVISION TO BURY SYSTEM DEEPER IT WAS FOUND THAT THE SKIN WAS TOO FRAIL AND INFLAMED SO THE SYSTEM WAS EXPLANTED TO REDUCE RISK OF POSSIBLE INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Fluid Discharge; Unspecified Infection
MAUDE report 25502464 ↗InjuryMay 26, 2026Migration or Expulsion of Device
PATIENT UNDERWENT FULL SYSTEM REVISION DUE TO LEAD MIGRATION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25286236 ↗InjuryMay 26, 2026Migration or Expulsion of Device
PT UNDERWENT FULL SYSTEM REVISION DUE TO LEAD MIGRATION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285834 ↗InjuryMay 19, 2026Activation, Positioning or Separation Problem
LEAD WAS EXPLANTED DURING DEVICE REPOSITIONING DUE TO NOT PROVIDING ENOUGH LEFT SIDED COVERAGE. NEW LEAD PLACED IN MORE OPTIMAL POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225063 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS SEEN IN OFFICE A COUPLE WEEKS AGO DUE TO CONTINUE LEG PAIN AFTER IMPLANT. IT WAS DETERMINED BY MD THAT A LEAD WAS PUSHING ON A NERVE AND A REVISION WAS ADVISED. HOWEVER, PATIENT ULTIMATELY DECIDED SHE WANTED AN EXPLANT AND NO LONGER WANTS THE STIM. DEVICE WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 25009108 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS SEEN IN OFFICE A COUPLE WEEKS AGO DUE TO CONTINUE LEG PAIN AFTER IMPLANT. IT WAS DETERMINED BY MD THAT A LEAD WAS PUSHING ON A NERVE AND A REVISION WAS ADVISED. HOWEVER PATIENT ULTIMATELY DECIDED SHE WANTED AN EXPLANT AND NO LONGER WANTS THE STIM. DEVICE WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 25009106 ↗InjuryApr 23, 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 24971723 ↗InjuryApr 23, 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 24971708 ↗InjuryApr 14, 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 24873485 ↗InjuryApr 14, 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 24873483 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE THERAPY. PATIENT REPORTED PAIN AND WEAKNESS IN BOTH LEGS AFTER THE IMPLANT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Inadequate Pain Relief; Limb Pain; Muscle Weakness/Atrophy
MAUDE report 24792030 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE THERAPY. PATIENT REPORTED PAIN AND WEAKNESS IN BOTH LEGS AFTER THE IMPLANT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Inadequate Pain Relief; Limb Pain; Muscle Weakness/Atrophy
MAUDE report 24792026 ↗InjuryMar 24, 2026Migration or Expulsion of Device
REPOSITIONED BILATERAL LEADS DUE TO SLIGHT LEAD MIGRATION. LEADS REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673289 ↗InjuryMar 24, 2026Migration or Expulsion of Device
REPOSITIONED BILATERAL LEADS DUE TO SLIGHT LEAD MIGRATION. LEADS REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673217 ↗InjuryMar 2, 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 24483041 ↗InjuryMar 2, 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 24483040 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD A STROKE AND BECAME WHEEL CHAIR BOUND. STRUGGLED TO MAINTAIN THERAPY AND SAYS IT IS NOT PROVIDING ENOUGH PAIN RELIEF. SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 24214598 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD A STROKE AND BECAME WHEELCHAIR BOUND. STRUGGLED TO MAINTAIN THERAPY AND SAYS IT IS NOT PROVIDING ENOUGH PAIN RELIEF. SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 24214271 ↗InjuryJan 22, 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 24156563 ↗MalfunctionJan 5, 2026Insufficient Device Problem Information
THIS LEAD WAS EXPLANTED AND REPLACED FOR BETTER COVERAGE AND PLACEMENT. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23970191 ↗MalfunctionJan 5, 2026Insufficient Device Problem Information
THIS LEAD WAS EXPLANTED AND REPLACED FOR BETTER COVERAGE AND PLACEMENT. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23969928 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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