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
All models of St. Jude Medical Infinity (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Infinity is a brain stimulation system with leads placed in the brain. The 307 reports mostly describe weak or failed stimulation, leads that migrate, and infections, with some reports of involuntary movements. There are 10 deaths and 297 injuries reported. A closed recall from October 2018 covers an electrode that may use the wrong material. Reports rose from 40 in the year before to 60 in the latest year.
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
- 306
- Deaths reported
- 10
- Injuries reported
- 296
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 306 adverse event reports that list this exact device (DI 05415067030320), received between Apr 8, 2019 and Sep 30, 2026 — classified as 10 deaths, 296 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (64 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 16, 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 Problem167
- Therapeutic or Diagnostic Output Failure64
- Migration24
- High impedance13
- Malposition of Device8
- Use of Device Problem8
- Insufficient Device Problem Information5
- Fracture4
Patient problems
- Movement Disorder61
- Unspecified Infection56
- Inadequate Pain Relief50
- No Clinical Signs, Symptoms or Conditions31
- Post Operative Wound Infection29
- Erosion20
- Wound Dehiscence14
- Skin Erosion8
Recent adverse event reports
The 25 most recent of 306 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50952989 ↗InjurySep 22, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced returning symptoms. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Movement Disorder
MAUDE report 50860270 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient had infection at the burr hole site. Investigation was unable to identify which burr hole cap attributed to the issue. Surgical intervention was undertaken wherein the left lead and burr hole were removed. Patient was prescribed anti-biotics to address the issue.
Patient problems: Unspecified Infection
MAUDE report 50828391 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient experienced worsening anxiety, suicidal thoughts, and depression. The patient was admitted for inpatient treatment.
Patient problems: Anxiety; Depression; Suicidal Ideation
MAUDE report 50530146 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following having the second lead implanted the patient couldn't walk and experienced speech issues. Suspected potential stroke post op. Additionally, it was reported that the patient was unable to place their system into MRI mode. Diagnostics revealed high impedances on the lead. Reprogramming was done to provide further symptom relief / speech improvement.
Patient problems: Ambulation or Postural Difficulties; Speech Disorder; Stroke/CVA
MAUDE report 50122648 ↗InjuryJul 30, 2026Migration
It was reported that imaging indicated the lead migrated after original placement. As a result, surgical intervention was undertaken on (b)(6) 2026 where the lead was replaced to address the issue. Therapy was not affected.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50077865 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
it was reported that patient experienced reduced wound healing in the right lead and burr hole cap site. As result, surgical intervention was undertaken wherein the lead and burr hole cap site was cleaned and sutured to address the issue.
Patient problems: Impaired Healing
MAUDE report 50072066 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT¿S BURR HOLE COVER WAS EXPOSED. THE SITE APPEARED INFECTED. THE PATIENT REPORTS A HARD FALL SEVERAL MONTHS PRIOR. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE LEAD AND BURR HOLE COVER WERE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 25752210 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2026 [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-07960, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-07961, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-07962, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-08731, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-08732] INFECTION WAS FOUND ONCE INCISION WAS MADE. THE PHYSICIAN WASHED THE SITE OUT WITH ANTIBIOTICS AND RECLOSED. IMPLANT CASE WAS ABANDONED.
Patient problems: Unspecified Infection
MAUDE report 25669474 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2026 [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-07960, RELATED MANUFACTURER REFERENCE NUMBER:1627487-2026-07961, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-07962, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-08731, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-08732] INFECTION WAS FOUND ONCE INCISION WAS MADE. THE PHYSICIAN WASHED THE SITE OUT WITH ANTIBIOTICS AND RECLOSED. IMPLANT CASE WAS ABANDONED.
Patient problems: Unspecified Infection
MAUDE report 25669454 ↗InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT LEAD WAS VISUALLY CONFIRMED TO BE FRACTURED AND WAS STICKING OUT OF THE SKIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE PATIENT'S RIGHT SIDED SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Skin Erosion
MAUDE report 25608454 ↗InjuryJun 24, 2026Fracture
IT WAS REPORTED THAT THE PATIENT'S RIGHT LEAD WAS VISUALLY CONFIRMED TO BE FRACTURED AND WAS STICKING OUT OF THE SKIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE PATIENT'S RIGHT SIDED SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 25608451 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED AN OPEN WOUND AT THE BURR HOLE COVER. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Erosion
MAUDE report 25071430 ↗InjuryApr 17, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED DUE TO POOR INITIAL PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24906259 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2026 TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 24867115 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2026 TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 24867114 ↗InjuryMar 31, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RETURNING SYMPTOMS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 24746265 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPEECH ISSUES FOLLOWING IMPLANT OF THE DBS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. IT IS UNKNOWN WHICH LEAD WAS AT FAULT.
Patient problems: Speech Disorder
MAUDE report 24692128 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENTS RIGHT LEAD ERODED THROUGH THE SKIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Erosion
MAUDE report 24612898 ↗InjuryMar 16, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE RIGHT LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 24611160 ↗InjuryMar 13, 2026Malposition of Device
ADDITIONAL INFORMATION RECEIVED INDICATES THAT EFFECTIVE THERAPY WAS CONFIRMED DURING POST OP PROGRAMMING.
Patient problems: Movement Disorder
MAUDE report 24594224 ↗InjuryMar 13, 2026Malposition of Device
ADDITIONAL INFORMATION RECEIVED INDICATES THAT EFFECTIVE THERAPY WAS CONFIRMED DURING POST OP PROGRAMMING.
Patient problems: Movement Disorder
MAUDE report 24594204 ↗InjuryMar 11, 2026Malposition of Device
ADDITIONAL INFORMATION INDICATES REPLACEMENT LEAD WAS IMPLANTED ON (B)(6) 2026.
Patient problems: Movement Disorder
MAUDE report 24570175 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE RIGHT LEAD AND BURR HOLE CAP SITE AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE RIGHT LEAD AND BURR HOLE CAP WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 24519982 ↗InjuryFeb 18, 2026High impedance
IT WAS REPORTED THE PATIENT UNDERWENT EXPLORATORY SURGERY ON 26JAN2026 WHERE IT WAS FOUND THE PATIENT'S LEAD AND EXTENSION EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24381504 ↗
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-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.
- 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
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 13, 2026 · each recall links to the FDA recall notice
- 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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