St. Jude Medical Infinity™ DBS System (REF 6372)Recalls & reported problems
St. Jude Medical, Inc. · 8CH Flex Extn, 60 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 extension has 263 adverse event reports, including 262 injuries, 1 malfunction and no deaths. Reports mostly describe high electrical resistance that left stimulation ineffective, and several describe the extensions being replaced in surgery, sometimes after tangling or damage during battery replacement. There are no recalls that 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
- 268
- Deaths reported
- 0
- Injuries reported
- 267
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 268 adverse event reports that list this exact device (DI 05415067030351), received between Oct 28, 2019 and Sep 29, 2026 — classified as 267 injuries, 1 malfunction.
The most frequently reported specific device problem is “High impedance” (110 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 impedance110
- Adverse Event Without Identified Device or Use Problem87
- Fracture27
- Low impedance17
- Impedance Problem10
- Migration6
- Insufficient Device Problem Information4
- Therapeutic or Diagnostic Output Failure4
Patient problems
- No Clinical Signs, Symptoms or Conditions67
- Movement Disorder64
- Inadequate Pain Relief48
- Failure of Implant37
- Unspecified Infection31
- Post Operative Wound Infection21
- Erosion14
- Undesired Nerve Stimulation11
Recent adverse event reports
The 25 most recent of 268 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026High impedance
It was reported that the patient experienced a shocking sensation and was unable to enter their device into MRI mode. Diagnostics revealed high impedances on bilateral extensions. As a result, surgical intervention was undertaken wherein the bilateral extensions were explanted and replaced to resolve the issue.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50933664 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced a shocking sensation and was unable to enter their device into MRI mode. Diagnostics revealed high impedances on bilateral extensions. As a result, surgical intervention was undertaken wherein the bilateral extensions were explanted and replaced to resolve the issue.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50933656 ↗InjurySep 17, 2026High impedance
It was reported the patient's leads had high impedances. Surgical intervention was undertaken wherein the leads were explanted and replaced to address the issue.
Patient problems: Movement Disorder
MAUDE report 50806844 ↗InjurySep 17, 2026High impedance
It was reported the patient's leads had high impedances. Surgical intervention was undertaken wherein the leads were explanted and replaced to address the issue.
Patient problems: Movement Disorder
MAUDE report 50806831 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fluid Discharge; Impaired Healing
MAUDE report 50794952 ↗InjurySep 14, 2026High impedance
It was reported that patient's system was unable to enter MRI mode. Troubleshooting revealed high impedances on the right lead. 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 50763996 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703216 ↗InjuryJul 27, 2026Use of Device Problem
It was reported that during a routine IPG replacement (b)(6) 2026 patients extension was damaged. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein extension was explanted and replaced to address the issue.
Patient problems: Foreign Body In Patient
MAUDE report 50041425 ↗InjuryJul 27, 2026High impedance
It was reported that the patient's right extension exhibited high impedances. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was explanted and replaced to address the issue. Therapy was restored post procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036879 ↗InjuryJul 27, 2026High impedance
It was reported that the patient experienced ineffective therapy following recent falls and a recent car accident. Diagnostics revealed high impedances on both extensions. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the extensions were replaced to address the issue.
Patient problems: Movement Disorder
MAUDE report 50025377 ↗InjuryJul 27, 2026High impedance
It was reported that the patient experienced ineffective therapy following recent falls and a recent car accident. Diagnostics revealed high impedances on both extensions. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the extensions were replaced to address the issue.
Patient problems: Movement Disorder
MAUDE report 50025375 ↗InjuryJul 10, 2026High impedance
IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO SET THE SYSTEM INTO MRI MODE DUE TO HIGH IMPEDANCES. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781215 ↗InjuryJun 18, 2026Low impedance
IT WAS REPORTED THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH AND LOW IMPEDANCES ON THE LEADS. PATIENT SLIGHTLY BUMPED THEIR HEAD. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 25552542 ↗InjuryJun 15, 2026High impedance
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH EXTENSIONS. SURGICAL INTERVENTION TOOK PLACE WHEREIN IT WAS NOTED THAT BOTH THE EXTENSIONS WERE TANGLED. AS SUCH, THE EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS ESTABLISHED.
Patient problems: Movement Disorder
MAUDE report 25503428 ↗InjuryJun 4, 2026High impedance
IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25397816 ↗InjuryJun 4, 2026High impedance
IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026, WHEREIN THE LEAD EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25397701 ↗InjuryMay 8, 2026High impedance
IT WAS REPORTED THAT AFTER A FALL THE PATIENT'S LEAD EXTENSIONS EXHIBITED HIGH IMPEDANCES RESULTING IN INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION HAS OCCURRED TO ADDRESS THE ISSUE BY REPLACING THE EXTENSIONS.
Patient problems: Movement Disorder
MAUDE report 25123125 ↗InjuryMay 8, 2026High impedance
IT WAS REPORTED THAT AFTER A FALL THE PATIENT'S LEAD EXTENSIONS EXHIBITED HIGH IMPEDANCES RESULTING IN INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION HAS OCCURRED TO ADDRESS THE ISSUE BY REPLACING THE EXTENSIONS.
Patient problems: Movement Disorder
MAUDE report 25123065 ↗InjuryApr 30, 2026High impedance
IT WAS REPORTED THAT THE PATIENT'S EXTENSION EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE EXTENSION WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044515 ↗InjuryApr 24, 2026High impedance
IT WAS REPORTED THAT THE PATIENT'S LEFT EXTENSION EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24981001 ↗InjuryApr 15, 2026Low impedance
IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED LOW IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief; Movement Disorder
MAUDE report 24885905 ↗InjuryApr 15, 2026Low impedance
IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED LOW IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief; Movement Disorder
MAUDE report 24885902 ↗InjuryMar 30, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE RIGHT LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE EXTENSION WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24731554 ↗InjuryMar 26, 2026High impedance
IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24705200 ↗InjuryMar 26, 2026High impedance
IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24705164 ↗
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-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-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
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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