St. Jude Medical Infinity™ DBS System (REF 6371)Recalls & reported problems
St. Jude Medical, Inc. · 8CH Flex Extn, 50 cm · Class 3 · Implant
All models of St. Jude Medical Infinity (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Infinity deep brain stimulation system appears in 265 adverse event reports, with no deaths and 263 injuries. The reports mostly describe high or low impedance readings, fractured or pulled-apart extensions, and ineffective therapy, with several leading to surgery to replace the extensions. Reports fell to 19 in the last 12 months from 32 in the year before. No recalls name this device.
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
- 263
- Deaths reported
- 0
- Injuries reported
- 261
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 263 adverse event reports that list this exact device (DI 05415067020307), received between Jun 12, 2018 and Jun 24, 2026 — classified as 261 injuries, 2 malfunctions.
The most frequently reported specific device problem is “High impedance” (117 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
- High impedance117
- Adverse Event Without Identified Device or Use Problem44
- Fracture35
- Impedance Problem23
- Low impedance17
- Use of Device Problem13
- Therapeutic or Diagnostic Output Failure10
- Break9
Patient problems
- Inadequate Pain Relief107
- No Clinical Signs, Symptoms or Conditions67
- Movement Disorder34
- Failure of Implant24
- Twiddlers Syndrome13
- Post Operative Wound Infection10
- Implant Pain9
- No Consequences Or Impact To Patient8
Recent adverse event reports
The 25 most recent of 263 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH BOTH (LEFT/RIGHT) DBS SYSTEM. IMPEDANCE CHECK REVEALED HIGH IMPEDANCE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXTENSIONS WERE EXPLANTED TO ADDRESS THE ISSUE. THE IMPEDANCE ON LEFT SIDE REMAINS. HOWEVER, EFFECTIVE THERAPY WAS ESTABLISHING VIA REPROGRAMING.
Patient problems: Movement Disorder
MAUDE report 25613036 ↗InjuryJun 11, 2026Impedance Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE EXTENSIONS WERE EXPLANTED AND REPLACED DUE TO INVALID IMPEDANCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476684 ↗InjuryJun 11, 2026Impedance Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE EXTENSIONS WERE EXPLANTED AND REPLACED DUE TO INVALID IMPEDANCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476676 ↗InjuryApr 15, 2026High impedance
IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE EXTENSION WAS EXPLANTED AND REPLACED, RESOLVING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889043 ↗InjuryApr 1, 2026High impedance
IT WAS REPORTED THAT AN INTRA OP IMPEDANCE CHECK DURING A STANDARD NORMAL END OF LIFE IPG REPLACEMENT PROCEDURE, HIGH IMPEDANCES WERE NOTED ON THE LEFT SIDE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, THE LEFT EXTENSION WAS EXPLANTED AND REPLACED RESOLVING THE ISSUE. THERAPY WAS CONFIRMED POST OP. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE EXTENSIONS HAD THE HIGH IMPEDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758929 ↗InjuryMar 13, 2026Fracture
IT WAS REPORTED THAT THE PATIENT HAD A FRACTURED LEAD EXTENSION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD EXTENSION WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593985 ↗InjuryJan 14, 2026Fracture
IT WAS REPORTED PATIENT'S LEFT EXTENSION WAS HAVING HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE, A WIRE WAS OBSERVED TO BE STICKING OUT OF THE EXTENSION. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH EXTENSION ATTRIBUTED TO THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 24070697 ↗InjuryJan 14, 2026Impedance Problem
IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 24069428 ↗InjuryJan 14, 2026High impedance; Impedance Problem
IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 24069425 ↗InjuryJan 7, 2026Low impedance; Impedance Problem
IT WAS REPORTED THAT THE PATIENT'S EXTENSIONS HAD HIGH AND LOW IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23999332 ↗InjuryJan 7, 2026High impedance; Impedance Problem
IT WAS REPORTED THAT THE PATIENT'S EXTENSIONS HAD HIGH AND LOW IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23999330 ↗InjuryDec 17, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ONE EXTENSION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED. THE INVESTIGATION WAS UNABLE TO DETERMINE THE EXTENSION THAT ASSOCIATED WITH THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 23830168 ↗InjuryDec 8, 2025Impedance Problem; Impedance Problem
IT WAS REPORTED THAT THE PATIENT'S IPG HAS REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION WAS UNDERTAKEN AND DURING THE PROCEDURE IT WAS ALSO DISCOVERED THE LEFT EXTENSION WAS DAMAGED AND WAS CAUSING IMPEDANCES, THE IPG AND EXTENSION WERE EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743370 ↗InjuryDec 3, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED DURING AN ELECTIVE IPG REPLACEMENT, THE EXTENSION WAS DAMAGED WHEN BEING REMOVED FROM THE EXPLANTED IPG, CAUSING ABNORMAL IMPEDANCES. AS A RESULT, THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708017 ↗InjuryDec 2, 2025High impedance; High impedance
IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE RIGHT EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23698215 ↗InjuryNov 24, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S EXTENSION HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE EXTENSION TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632307 ↗InjuryNov 17, 2025High impedance; Impedance Problem; High impedance; Impedance Problem
ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT HAD INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THEIR EXTENSION.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 23571199 ↗InjuryOct 15, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN IPG REVISION PROCEDURE ON (B)(6) 2025, THE PATIENT HAD FRACTURED EXTENSIONS THAT WERE CONFIRMED VISUALLY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 23306998 ↗InjuryOct 15, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN IPG REVISION PROCEDURE ON (B)(6) 2025, THE PATIENT HAD FRACTURED EXTENSIONS THAT WERE CONFIRMED VISUALLY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 23306997 ↗InjurySep 3, 2025High impedance; High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED LOSS OF STIMULATION. DIAGNOSTICS REVEALED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 22960049 ↗InjuryJul 28, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S RIGHT EXTENSION HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE EXTENSION WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22638818 ↗InjuryJul 9, 2025High impedance; High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY PATIENT HAD HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 22464835 ↗InjuryJun 19, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT HAD LOW IMPEDANCES. DURING SURGERY, IT WAS CONFIRMED RIGHT EXTENSION WAS FRAYED AND FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief; Movement Disorder
MAUDE report 22292205 ↗InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT'S EXTENSION SITES WERE NOT HEALING COMPLETELY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: Wound Dehiscence
MAUDE report 22087621 ↗InjuryMay 20, 2025High impedance; High impedance
ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, IT WAS NOTICED DURING SURGERY THAT ONE OF THE EXTENSIONS HAD FRACTURED. THE INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEAD EXTENSION HAD FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22057371 ↗
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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