Prospera IPGRecalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Quick summary
This Biotronik Prospera spinal cord stimulator is an implanted device that sends electrical pulses to relieve pain. Its 185 reports include no deaths and 174 injuries. Many describe removing the system over inadequate pain relief, pain at the battery site, charging trouble, or infection. No recalls name this device.
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
- 192
- Deaths reported
- 0
- Injuries reported
- 181
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 04035479170110), received between Jul 17, 2023 and Sep 30, 2026 — classified as 181 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, 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 Problem159
- 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
Recent adverse event reports
The 25 most recent of 192 reports, 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 ↗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 25587862 ↗InjuryJun 9, 2026Migration or Expulsion of Device; Charging Problem
THIS DEVICE WAS REPOSITIONED DUE TO IT FLIPPED IN THE POCKET RESULTING IN DIFFICULTY CHARGING. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450419 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO WOUND DEHISCENCE AND RISK OF INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 25450048 ↗InjuryJun 9, 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 25449609 ↗InjuryJun 9, 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 25449607 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
DEVICE WAS REPOSITIONED DUE TO PATIENT COMPLAINT OF DISCOMFORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 25449571 ↗InjuryJun 3, 2026Insufficient Device Problem Information
PATIENT REPORTED THAT STIM CAUSING NUMBNESS IN UPPER BACK. THE DEVICE WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Numbness
MAUDE report 25380225 ↗InjuryJun 2, 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 25360134 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO STAPH INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25320569 ↗InjuryMay 27, 2026Charging Problem
SYSTEM WAS REMOVED DUE TO CHARGING DIFFICULTY AND INEFFECTIVE PAIN RELIEF. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Inadequate Pain Relief
MAUDE report 25308663 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.