St. Jude Medical Infinity™ DBS System (REF 6170)Recalls & reported problems
St. Jude Medical, Inc. · 8CH Directional Lead, 30 cm, 0.5 · Class 3 · Implant
All models of St. Jude Medical Infinity (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05415067030306), received between Jan 11, 2021 and Nov 18, 2025 — classified as 17 injuries.
The most frequently reported specific device problem is “High impedance” (2 reports).
1 FDA recall record name this device's identifier.
5 other recalls cover devices cleared under the same FDA submission (P140009); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Recalls naming this device
- Oct 11, 2018Class IITerminated
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Z-0593-2019 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- High impedance2
- Fracture1
- Migration1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Unspecified Infection6
- Inadequate Pain Relief2
- Balance Problems1
- Hemorrhage/Blood Loss/Bleeding1
- Inflammation1
- Intracranial Hemorrhage1
- Movement Disorder1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR BALANCE DETERIORATION AND THE SYMPTOMS HAVE SINCE RESOLVED.
Patient problems: Balance Problems
MAUDE report 23586948 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS AND INFECTION HAS RESOLVED.
Patient problems: Post Operative Wound Infection
MAUDE report 22882366 ↗InjuryJun 23, 2025High impedance; High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEAD HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN LEAD AND EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 22311798 ↗InjuryApr 30, 2025Migration; Migration
IT WAS REPORTED THAT FOLLOWING CT SCAN AFTER IMPLANT PROCEDURE, IT WAS REVEALED THAT PATIENTS LEAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN ON (B)(6) 2025 WHEREIN LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938981 ↗InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 1627487-2024-00008. IT WAS REPORTED THAT WOUND DEHISCENCE WAS OBSERVED AT THE PATIENT'S RIGHT DBS LEAD SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE RIGHT LEAD AND BURR HOLE COVER WERE EXPLANTED, RESOLVING THE ISSUE. THE PATIENT WAS PUT ON ANTIBIOTICS POST-OPERATIVELY.
Patient problems: Unspecified Infection
MAUDE report 18429267 ↗InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THE INFECTION HAS RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 18372066 ↗InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THE INFECTION HAS RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 18372054 ↗InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-05732, 1627487-2023-05733, 1627487-2023-05734, 1627487-2023-05736. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THROUGH THE DBS SYSTEM. AS A RESULT THE SYSTEM WAS EXPLANTED. FOLLOW UP INDICATED THE PATIENT'S INFECTION RESOLVED WITHOUT SEQUELAE.
Patient problems: Unspecified Infection
MAUDE report 18253865 ↗InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-05732, 1627487-2023-05733, 1627487-2023-05735, 1627487-2023-05736. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THROUGH THE DBS SYSTEM. AS A RESULT THE SYSTEM WAS EXPLANTED. FOLLOW UP INDICATED THE PATIENT'S INFECTION RESOLVED WITHOUT SEQUELAE.
Patient problems: Unspecified Infection
MAUDE report 18253861 ↗InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL WITH FEVER SYMPTOMS, SHIVERING AND HALLUCINATIONS. IT WAS THEN DISCOVERED THE PATIENT HAD A UTI AND WAS DISCHARGED FROM THE HOSPITAL WITH ANTIBIOTICS. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD CONTRIBUTED TO THIS ISSUE. FURTHER INTERVENTION MAY BE PENDING.
Patient problems: Urinary Tract Infection
MAUDE report 17128374 ↗InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE AT THE LEAD SITE. AS SUCH, THE PATIENT RECEIVED ADJUSTED MEDICATION THERAPY AND SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Wound Dehiscence
MAUDE report 16910982 ↗InjuryApr 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED A CEREBRAL HEMORRHAGE POST IMPLANT PROCEDURE. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE RIGHT DBS LEAD WAS EXPLANTED, ADDRESSING THE ISSUE.
Patient problems: Intracranial Hemorrhage
MAUDE report 16705337 ↗InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00696,1627487-2023-01018, 1627487-2023-01019, AND 1627487-2023-01020. IT WAS REPORTED THE PATIENT'S SCALP SUTURE HAD DEHISCENCE RESULTING IN ADDITIONAL SURGERY ON (B)(6) 2023 TO REPAIR THE SUTURE. ADDITIONAL INFORMATION WAS RECEIVED WHEREIN THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO INFECTION TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 16506396 ↗InjuryNov 1, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION DUE TO MISPLACEMENT OF THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 15708248 ↗InjuryOct 12, 2022Fracture; High impedance; Fracture; High impedance
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES, AND THEN IT WAS LATER DISCOVERED THAT THE LEAD WAS FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 15591518 ↗InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE ON THE RIGHT SIDE. MEDICATION WAS ADMINISTERED. THE BLEEDING HAS SINCE BEEN RESOLVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15265491 ↗InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT 1627487-2021-00213, RELATED MANUFACTURER REPORT 1627487-2021-00214. IT WAS REPORTED THAT PATIENT EXPERIENCED A TRAUMA RESULTING IN DEVELOPING A SCAB ON THE BURR HOLE LOCATION RESULTING IN INFLAMMATION AND FESTERING SECRETION. THE LEAD AND THE BURR HOLE COVERS WERE EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Inflammation
MAUDE report 11145732 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140009. One submission often covers many models, so check the product and lot details in each record.
- Z-0459-2026 · Oct 6, 2025 · Open, ClassifiedLiberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
- Z-2695-2017 · Jun 2, 2017 · TerminatedInfinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
- Z-2694-2017 · Jun 2, 2017 · TerminatedInfinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
- Z-2696-2017 · Jun 2, 2017 · TerminatedInfinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
- Z-2693-2017 · Jun 2, 2017 · TerminatedInfinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions.
Other STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR devices
- Activa® RC 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 deaths1,849 reports
- Activa® 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR8 deaths1,093 reports
- Infinity™ 6662St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths803 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths751 reports
- Activa® SC 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall1 death443 reports
- Infinity™ 7St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls3 deaths368 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR406 reports
- Activa® RC 37612Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian tremor2 deaths371 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 · each recall links to the FDA recall notice
- 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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