ProsperaRecalls & reported problems across all models
BIOTRONIK SE & Co. KG · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 193
- Deaths reported
- 0
- Injuries reported
- 182
- Recalls
- 0
We found 2 models of Prospera by BIOTRONIK SE & Co. KG in the FDA's device registry (GUDID). Together they are named in 193 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2023 and Sep 30, 2026 — classified as 182 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (11 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 Prospera problems
Device problems
- Adverse Event Without Identified Device or Use Problem160
- Charging Problem11
- Migration or Expulsion of Device6
- Inappropriate/Inadequate Shock/Stimulation3
- Malposition of Device3
- Defibrillation/Stimulation Problem2
- Excessive Heating2
- Failure to Charge2
Patient problems
- Unspecified Infection67
- Inadequate Pain Relief54
- Implant Pain25
- No Clinical Signs, Symptoms or Conditions17
- Discomfort16
- Wound Dehiscence7
- Weight Changes5
- Fall3
Prospera models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prospera IPGStimulator, spinal-cord, totally implanted for pain relief192 reports
- Prospera Trial AccStimulator, spinal-cord, totally implanted for pain relief1 report
Recent Prospera adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation
This device was explanted due to occasional shocking at IPG site. Should additional information become available, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948329 ↗InjurySep 30, 2026Migration or Expulsion of Device
This device was repositioned due to it was moving in the original pocket location. It remains implanted. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946284 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
This device was repositioned due to patient complaint of pain at implant site. Should additional information be received this file will be updated.
Patient problems: Implant Pain
MAUDE report 50946091 ↗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 50885908 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50874111 ↗InjurySep 23, 2026Malposition of Device; Charging Problem
This device was explanted due to charging difficulties. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873808 ↗InjurySep 23, 2026Charging Problem
This device was explanted due to difficulty charging and patient report of a fall. Should additional information be received this file will be updated.
Patient problems: Fall
MAUDE report 50873688 ↗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 50804719 ↗InjurySep 16, 2026Connection Problem
Patient problems: Fall
MAUDE report 50794500 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50740074 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50740072 ↗InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem
THIS IPG WAS SUCCESSFULLY REPOSITIONED AFTER PATIENT COMPLAINED OF DISCOMFORT. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 25761977 ↗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 25691426 ↗InjuryJun 30, 2026Charging Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINT OF DISCOMFORT AT IPG SITE AS A RESULT OF WEIGHT LOSS. PATIENT WAS ALSO NOT GETTING ADEQUATE PAIN RELIEF DUE TO CHARGING ISSUES.
Patient problems: Discomfort; Inadequate Pain Relief; Weight Changes
MAUDE report 25667439 ↗InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO PATIENT COMPLAINT OF PAIN AT BATTERY SITE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 25600253 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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