ResilienceRecalls & reported problems across all models
BIOTRONIK SE & Co. KG · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 417
- Deaths reported
- 0
- Injuries reported
- 380
- Recalls
- 0
We found 4 models of Resilience by BIOTRONIK SE & Co. KG in the FDA's device registry (GUDID). Together they are named in 417 adverse event reports in the FDA's MAUDE database, received between May 25, 2023 and Sep 30, 2026 — classified as 380 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (84 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Resilience problems
Device problems
- Adverse Event Without Identified Device or Use Problem307
- Migration or Expulsion of Device84
- Device Dislodged or Dislocated7
- Impedance Problem5
- Positioning Problem5
- Inappropriate/Inadequate Shock/Stimulation3
- Activation, Positioning or Separation Problem2
- Defibrillation/Stimulation Problem2
Patient problems
- Unspecified Infection139
- Inadequate Pain Relief126
- No Clinical Signs, Symptoms or Conditions72
- Implant Pain22
- Fall14
- Wound Dehiscence14
- Pain12
- Discomfort7
Resilience models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Resilience 55Stimulator, spinal-cord, totally implanted for pain relief320 reports
- Resilience 75Stimulator, spinal-cord, totally implanted for pain relief72 reports
- Resilience 55TRStimulator, spinal-cord, totally implanted for pain relief21 reports
- Resilience 75TRStimulator, spinal-cord, totally implanted for pain relief4 reports
Recent Resilience adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗
Other BIOTRONIK SE & Co. KG products
All BIOTRONIK SE & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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