St. Jude Medical Infinity™ DBS System (REF 6172)Recalls & reported problems
St. Jude Medical, Inc. · 8CH Directional Lead, 40 cm, 0.5 · Class 3 · Implant
Quick summary
This St. Jude Medical Infinity deep brain stimulation system has 752 reports, with 3 deaths and 127 injuries. Most reports describe parts assembled incorrectly, and some describe leads that moved out of place, weak therapy, and infections. Reports fell to 1 in the past 12 months from 8 in the 12 months before. A recall that started in October 2018 is closed; it concerns a lead electrode that may be made of a different metal than specified.
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
- 751
- Deaths reported
- 3
- Injuries reported
- 126
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 751 adverse event reports that list this exact device (DI 05415067020680), received between Jul 10, 2018 and Aug 25, 2025 — classified as 3 deaths, 126 injuries, 622 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (621 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Oct 11, 2018Terminated
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 · FDA record ↗
Most reported problems
Device problems
- Component Misassembled621
- Adverse Event Without Identified Device or Use Problem72
- Therapeutic or Diagnostic Output Failure22
- High impedance16
- Impedance Problem7
- Fracture5
- Migration4
- No Apparent Adverse Event4
Patient problems
- No Consequences Or Impact To Patient628
- Inadequate Pain Relief46
- Unspecified Infection19
- Post Operative Wound Infection9
- Erosion8
- Movement Disorder8
- No Clinical Signs, Symptoms or Conditions8
- Discomfort5
Recent adverse event reports
The 25 most recent of 751 reports, in the reporter's own words as published by the FDA.
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 22882404 ↗InjuryJul 10, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION BECAUSE THE LEADS HAD MIGRATED. THE ISSUE WAS CONFIRMED VIA IMAGING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 22473438 ↗InjuryJul 10, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION BECAUSE THE LEADS HAD MIGRATED. THE ISSUE WAS CONFIRMED VIA IMAGING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 22473432 ↗InjuryMay 15, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY WITH THEIR DBS SYSTEM DUE TO PLACEMENT OF THE LEFT DBS LEAD WHICH WAS NOT IDEAL. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE, WHEREIN THE DBS LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 22023630 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INFECTION WAS JUST AT A SINGLE SITE (RIGHT SITE). REPORTEDLY, THE INFECTION HAS BEEN RESOLVED AND THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL. THE SERIAL NUMBER FOR THE RIGHT LEAD AND EXTENSION ARE (B)(6). THE LOT NUMBER FOR THE RIGHT BURR HOLE CAP SYSTEM IS 10161274.
Patient problems: Unspecified Infection
MAUDE report 21597719 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INFECTION WAS JUST AT A SINGLE SITE (RIGHT SITE). REPORTEDLY, THE INFECTION HAS BEEN RESOLVED AND THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL. THE SERIAL NUMBER FOR THE RIGHT LEAD AND EXTENSION ARE (B)(6). THE LOT NUMBER FOR THE RIGHT BURR HOLE CAP SYSTEM IS 10161274.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 21597712 ↗InjuryJan 1, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS AUTO REDUCING DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG, LEAD AND EXTENSION WERE EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; Inadequate Pain Relief; Movement Disorder
MAUDE report 21052205 ↗InjuryNov 13, 2024Impedance Problem; Impedance Problem
IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO PUT THEIR RIGHT SYSTEM INTO MRI MODE. TROUBLESHOOTING TOOK PLACE BUT WERE UNABLE TO CONNECT TO THE DEVICE. SURGICAL INTERVENTION TOOK PLACE WHERE THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20678200 ↗InjuryJun 17, 2024Low impedance; Low impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTIC RECORDED LOW IMPEDANCES. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT WAS ASSOCIATED WITH THE ISSUE.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 19554546 ↗InjuryFeb 14, 2024High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCES. THE PATIENT HAS HAD A FEW FALLS OVER THE PAST FEW MONTHS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD HAS HIGH IMPEDANCES.
Patient problems: Inadequate Pain Relief
MAUDE report 18707657 ↗InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04103, 1627487-2023-04104, 1627487-2023-04106, 1627487-2023-04107, 1627487-2023-04108, 1627487-2023-04109. IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION ALL ALONG THE PATH OF BOTH THE GENERATOR AND THE LEADS. IT WAS NOTED THAT THERE WAS PUS PRESENT, AND PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED. PATIENT IS BETTER NOW AND STABLE.
Patient problems: Purulent Discharge; Unspecified Infection
MAUDE report 17638937 ↗InjuryJun 8, 2023Impedance Problem; Impedance Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO INVALID IMPEDANCES. PRIOR TO SURGERY, THE DOCTOR WAS ABLE TO CLEAR THE IMPEDANCE ISSUE. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 TO ADD A THIRD LEAD. PATIENT NOW HAS EFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 17091864 ↗InjuryMay 30, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO THE LEAD NOT BEING PLACED WELL INITIALLY. AS A RESULT, THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED.
Patient problems: Movement Disorder
MAUDE report 17018871 ↗InjuryApr 13, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00110. IT WAS REPORTED THAT DURING THE LEFT LEAD REVISION PROCEDURE DUE TO LOW IMPEDANCE (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00110), THE RIGHT LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD AS IT NEEDED BETTER PLACEMENT.
Patient problems: Inadequate Pain Relief; Movement Disorder
MAUDE report 16732635 ↗InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT LEAD WAS PROTRUDING THROUGH THEIR SKIN. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD CAUSED THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEAD WAS EXPLANTED.
Patient problems: Skin Erosion
MAUDE report 16372159 ↗InjuryJan 9, 2023Low impedance; Impedance Problem; Low impedance; Impedance Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00111. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00112. IT WAS REPORTED THAT PATIENT WAS NOT RECEIVING THERAPY DUE TO IMPEDANCE ISSUE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHEREIN THE EXTENSION WERE EXPLANTED AND REPLACED WITH NEW EXTENSIONS. HOWEVER, THE ISSUE WAS NOT RESOLVED. FURTHER IMPEDANCE TESTING REVEALED THAT THE IMPEDANCE WAS ON THE LEFT LEAD. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief; Movement Disorder
MAUDE report 16121691 ↗InjuryJul 28, 2022Impedance Problem; Impedance Problem
IT WAS REPORTED THE PATIENT'S LEAD HAS IMPEDANCE ISSUES. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15121738 ↗InjuryJun 28, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE LEAD WAS MISPLACED DURING THE IMPLANT PROCEDURE, BEING INTRAVENTRICULAR AND NOT POSTERIOR, CONFIRMED BY A CT SCAN. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN THE DAY AFTER IMPLANT TO REMOVE THE LEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14846352 ↗InjuryJun 23, 2022High impedance; High impedance
IT WAS REPORTED THE PATIENTS LEAD DISPLAYS HIGH IMPEDANCE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 14792468 ↗InjuryJun 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE LEAD WAS FRACTURED AND SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14792427 ↗InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-01432. IT WAS REPORTED THAT PATIENT EXPERIENCED INFECTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD AND THE GUARDIAN WERE EXPLANTED. REPORTEDLY, THE INFECTION HAS RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 13793285 ↗InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2021-18936, 1627487-2021-18937, 1627487-2022-00825. IT WAS REPORTED THAT THE LEAD SITE WOUND HAD FLUID DISCHARGE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD AN ALLERGIC REACTION ON THE SKIN OF THE FOREHEAD AND AROUND THE CRANIAL WOUND. THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS, SURGERY MAY HAVE OCCURRED ON (B)(6) 2021 TO WASH OUT THE WOUND, AND PATIENT WAS HOSPITALIZED TO ADDRESS THE ISSUE. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL. THE ISSUE RESOLVED WITHOUT SEQUELAE.
Patient problems: Fluid Discharge; Hypersensitivity/Allergic reaction
MAUDE report 13520231 ↗InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER 1627487-2022-00149. RELATED MANUFACTURER REPORT NUMBER 1627487-2022-00150. RELATED MANUFACTURER REPORT NUMBER 1627487-2022-00152. IT WAS REPORTED THAT POTENTIAL INFECTION ISSUE WAS SUSPECTED AT THE LEAD SITE. THE SYSTEM WAS EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 13226914 ↗InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER 1627487-2022-00149. RELATED MANUFACTURER REPORT NUMBER 1627487-2022-00150. RELATED MANUFACTURER REPORT NUMBER 1627487-2022-00151. IT WAS REPORTED THAT POTENTIAL INFECTION ISSUE WAS SUSPECTED AT THE LEAD SITE. THE SYSTEM WAS EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 13226823 ↗InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00036. IT WAS REPORTED THAT PATIENT EXPERIENCED PSYCHOTIC EPISODES POST DBS IMPLANT. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Cognitive Changes
MAUDE report 13186015 ↗
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-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.
- 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-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
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
- 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
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall10 deaths306 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.