BIOTRONIK TrueLockRecalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
The BIOTRONIK TrueLock is an implanted spinal cord stimulator used for pain relief. The 47 reports mostly describe infections at the incision or battery pocket, along with wound reopening, clear fluid draining from incision sites, and leads shifting position within the body, with several systems removed or revised as a result. All 47 reports involve injuries and no deaths. There are no recalls naming this device. Reports rose from 12 in the earlier 12 months to 32 in the most recent 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
- 48
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04035479176136), received between Aug 28, 2024 and Sep 17, 2026 — classified as 48 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (6 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 Problem42
- Migration or Expulsion of Device6
Patient problems
- Unspecified Infection40
- No Clinical Signs, Symptoms or Conditions6
- Wound Dehiscence3
- Implant Pain2
- Fluid Discharge1
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 48 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 infection. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50804900 ↗InjurySep 15, 2026Migration or Expulsion of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782122 ↗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 25502475 ↗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 25450249 ↗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 25450037 ↗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 25320927 ↗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 25285761 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO POSSIBLE INFECTION AT BATTERY POCKET. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25216973 ↗InjuryMay 19, 2026Migration or Expulsion of Device
THIS ANCHOR WAS EXPLANTED DUE TO LEAD MIGRATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216912 ↗InjuryMay 12, 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 25155694 ↗InjuryMay 8, 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 25128674 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO BATTERY SITE INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25052107 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
PT IPG SITE BECAME INFECTED AND SYSTEM WAS EXPLANTED. PT IS NOW ON A COURSE OF ANTIBIOTICS AND DOING WELL.
Patient problems: Unspecified Infection
MAUDE report 25051879 ↗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 24971649 ↗InjuryApr 20, 2026Migration or Expulsion of Device
THIS ANCHOR WAS EXPLANTED 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 24923677 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO RECOMMENDATION FROM INFECTIOUS DISEASE DOCTORS; POTENTIAL INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24872411 ↗InjuryApr 14, 2026Migration or Expulsion of Device
THIS ANCHOR WAS EXPLANTED DUE TO LEAD MIGRATION LEADING TO HIGH IMPEDANCES. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871311 ↗InjuryMar 30, 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 24727201 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO MIDLINE AND POCKET INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24572155 ↗InjuryMar 5, 2026Migration or Expulsion of Device
THIS ANCHOR WAS EXPLANTED ALONG WITH THE LEAD DUE TO MIGRATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24526517 ↗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 24483116 ↗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 24483109 ↗InjuryFeb 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 24414038 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD STAPH INFECTION AND STIMULATOR SYSTEM WAS REMOVED (B)(6) 2026. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24307406 ↗InjuryFeb 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 24242295 ↗
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.
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