St. Jude Medical Infinity™ DBS System (REF 6373)Recalls & reported problems
St. Jude Medical, Inc. · 8CH Flex Extn, 90 cm · 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
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05415067020864), received between Jan 4, 2021 and May 6, 2025 — classified as 21 injuries.
The most frequently reported specific device problem is “Fracture” (5 reports).
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Fracture5
- High impedance3
- Difficult to Insert2
- Impedance Problem2
- Mechanical Jam2
Patient problems
- Movement Disorder6
- Failure of Implant5
- No Clinical Signs, Symptoms or Conditions5
- Unspecified Infection5
- Inadequate Pain Relief4
- Erosion2
- Twiddlers Syndrome2
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2025Fracture; Fracture
IT WAS REPORTED THAT PATIENTS LEADS HAVE HIGH IMPEDANCES, PATIENTS' EXTENSIONS WERE FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 21972990 ↗InjuryMay 6, 2025Fracture; Fracture
IT WAS REPORTED THAT PATIENT'S LEADS HAVE HIGH IMPEDANCES, PATIENT'S EXTENSIONS WERE FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 21972975 ↗InjuryJul 3, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING THE PATIENT'S UNRELATED ELECTIVE IPG REPLACEMENT ON (B)(6) 2024, THE PHYSICIAN HAD TROUBLE UNSCREWING THE LEAD EXTENSIONS FROM THE IPG HEADER, AND HAD DAMAGED THEM. AS A RESULT, LEAD EXTENSIONS WERE EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19671196 ↗InjuryJul 3, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING THE PATIENT'S UNRELATED ELECTIVE IPG REPLACEMENT ON (B)(6) 2024, THE PHYSICIAN HAD TROUBLE UNSCREWING THE LEAD EXTENSIONS FROM THE IPG HEADER, AND HAD DAMAGED THEM. AS A RESULT, LEAD EXTENSIONS WERE EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19671175 ↗InjuryMar 8, 2024Fracture; Impedance Problem; Fracture; Impedance Problem
RELATED MANUFACTURER REPORT NUMBER 1627487-2024-07386 AND 1627487-2024-07388. IT WAS REPORTED THE DEVICE DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR MESSAGE AND IT IS UNKNOWN IF THE DEVICE DEPLETED PREMATURELY. PRIOR TO THE SURGERY IT WAS DISCOVERED THE EXTENSIONS HAD IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN THE IPG, AND EXTENSIONS WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 18866988 ↗InjuryMar 8, 2024Fracture; Impedance Problem; Fracture; Impedance Problem
RELATED MANUFACTURER REPORT NUMBER 1627487-2024-07386 AND 1627487-2024-07387 IT WAS REPORTED THE DEVICE DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR MESSAGE AND IT IS UNKNOWN IF THE DEVICE DEPLETED PREMATURELY. PRIOR TO THE SURGERY IT WAS DISCOVERED THE EXTENSIONS HAD IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN THE IPG, AND EXTENSIONS WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 18866955 ↗InjuryFeb 2, 2024High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2024-00326. IT WAS REPORTED THE EXTENSIONS WERE REPLACED DUE TO HIGH IMPEDANCE AND FRACTURE.
Patient problems: Inadequate Pain Relief; Movement Disorder
MAUDE report 18631225 ↗InjuryFeb 2, 2024Fracture; Fracture
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2024-00327. IT WAS REPORTED THE EXTENSIONS WERE REPLACED DUE TO HIGH IMPEDANCE AND FRACTURE.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 18631124 ↗InjuryOct 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION INDICATES THE INFECTION HAS SINCE BEEN RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 17936983 ↗InjuryOct 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION INDICATES THE INFECTION HAS SINCE BEEN RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 17936982 ↗InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED. RELATED MANUFACTURING REPORT: 1627487-2023-04605, 1627487-2023-04606, 1627487-2023-04607, 1627487-2023-04609, 1627487-2023-04610, 1627487-2023-04611, 1627487-2023-04612.
Patient problems: Unspecified Infection
MAUDE report 17834442 ↗InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED. RELATED MANUFACTURING REPORT: 1627487-2023-04605, 1627487-2023-04606, 1627487-2023-04608, 1627487-2023-04609, 1627487-2023-04610, 1627487-2023-04611, 1627487-2023-04612.
Patient problems: Unspecified Infection
MAUDE report 17834289 ↗InjuryMar 16, 2023High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S EXTENSION WAS SHOWING HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE EXTENSION WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16553946 ↗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, 1627487-2023-01017, 1627487-2023-01018,1627487-2023-01020. 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 16506377 ↗InjuryFeb 9, 2023Difficult to Insert; Difficult to Insert
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-00610. IT WAS REPORTED THAT DURING A DBS IPG REPLACEMENT SURGERY ON (B)(6) 2023 THE PHYSICIAN WAS HAVING DIFFICULTY INSERTING THE LEAD EXTENSIONS INTO THE IPG. THE LEAD EXTENSIONS WERE EXPLANTED AND REPLACED TO COMPLETE THE DBS REPLACEMENT SURGERY. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16337011 ↗InjuryFeb 9, 2023Difficult to Insert; Difficult to Insert
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-00611. IT WAS REPORTED THAT DURING A DBS IPG REPLACEMENT SURGERY ON (B)(6) 2023 THE PHYSICIAN WAS HAVING DIFFICULTY INSERTING THE LEAD EXTENSIONS INTO THE IPG. THE LEAD EXTENSIONS WERE EXPLANTED AND REPLACED TO COMPLETE THE DBS REPLACEMENT SURGERY. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16336975 ↗InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-00218, 1627487-2022-00219, 1627487-2022-00220. IT WAS REPORTED THAT PATIENT EXPERIENCED SKIN EROSION AT THE LEAD AND EXTENSION SITE. THE PATIENT WAS GIVEN ANTIBIOTICS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 IN WHICH THE LEADS AND EXTENSIONS WERE EXPLANTED, RESOLVING THE ISSUE.
Patient problems: Erosion
MAUDE report 13232072 ↗InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-00218, 1627487-2022-00219, 1627487-2022-00221. IT WAS REPORTED THAT PATIENT EXPERIENCED SKIN EROSION AT THE LEAD AND EXTENSION SITE. THE PATIENT WAS GIVEN ANTIBIOTICS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 IN WHICH THE LEADS AND EXTENSIONS WERE EXPLANTED, RESOLVING THE ISSUE.
Patient problems: Erosion
MAUDE report 13232070 ↗InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00043. IT WAS REPORTED THAT THE PATIENT'S LEAD EXTENSION TAILS WERE SIGNIFICANTLY TANGLED DUE TO TWIDDLING. IN TURN, BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief; Twiddlers Syndrome
MAUDE report 13173705 ↗InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00042. IT WAS REPORTED THAT THE PATIENT'S LEAD EXTENSION TAILS WERE SIGNIFICANTLY TANGLED DUE TO TWIDDLING. IN TURN, BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief; Twiddlers Syndrome
MAUDE report 13173704 ↗InjuryJan 4, 2021High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S EXTENSION WAS DISPLAYING HIGH IMPEDANCES. AS A RESULT, THE EXTENSION WAS REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 11111077 ↗
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-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-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 16, 2026
- 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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