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 DBS extension is an implanted part that connects leads to the stimulator. Its 405 adverse event reports often describe high electrical resistance readings, bent or fractured extensions, and weaker therapy, and some describe leads disconnecting. The reports include no deaths and 403 injuries. 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
- 406
- Deaths reported
- 0
- Injuries reported
- 404
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 406 adverse event reports that list this exact device (DI 05415067030344), received between Sep 25, 2019 and Sep 25, 2026 — classified as 404 injuries, 2 malfunctions.
The most frequently reported specific device problem is “High impedance” (116 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 Problem152
- High impedance116
- Material Twisted/Bent32
- Fracture27
- Impedance Problem21
- Therapeutic or Diagnostic Output Failure18
- Migration15
- Use of Device Problem14
Patient problems
- Movement Disorder89
- No Clinical Signs, Symptoms or Conditions76
- Inadequate Pain Relief75
- Unspecified Infection58
- Post Operative Wound Infection34
- Failure of Implant33
- Implant Pain24
- Twiddlers Syndrome17
Recent adverse event reports
The 25 most recent of 406 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Failure to Deliver Energy
It was reported that patients system was auto reducing. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Movement Disorder
MAUDE report 50903696 ↗InjurySep 23, 2026High impedance
Patient problems: Movement Disorder
MAUDE report 50875987 ↗InjurySep 23, 2026High impedance
Patient problems: Movement Disorder
MAUDE report 50875956 ↗InjurySep 21, 2026High impedance
It was reported that patient was unable to enter MRI mode due to high impedance. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein extension was unplugged whipped off and reinserted to address the issues. Impedance cleared.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846235 ↗InjuryAug 18, 2026Use of Device Problem
It was reported that during the IPG replacement procedure on (b)(6) 2026 one of the extensions was inadvertently damaged. As a result, both extensions were replaced as scar tissue prevented clean removal of only one.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307774 ↗InjuryJul 31, 2026Use of Device Problem
It was reported that during an IPG explant (ref manufact number:(b)(4)) the extensions were cut and remained implanted. In turn, surgical intervention may be pending to address this issue.
Patient problems: Foreign Body In Patient
MAUDE report 50097182 ↗InjuryJul 31, 2026Use of Device Problem
It was reported that during an IPG explant (ref manufact number:1627487-2026-08151) the extensions were cut and remained implanted. In turn, surgical intervention may be pending to address this issue.
Patient problems: Foreign Body In Patient
MAUDE report 50097181 ↗InjuryJul 28, 2026High impedance
It was reported that the patient's right lead 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057334 ↗InjuryJul 18, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON BOTH EXTENSIONS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 25867145 ↗InjuryJul 18, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON BOTH EXTENSIONS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 25867144 ↗InjuryJun 29, 2026Disconnection
IT WAS REPORTED THAT THE PATIENT¿S THERAPY STRENGTH WAS DECREASING ON ITS OWN. X-RAY IMAGING REVEALED THE LEADS HAD DISCONNECTED FROM THE EXTENSIONS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST OP.
Patient problems: Movement Disorder
MAUDE report 25656637 ↗InjuryJun 24, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH BOTH (LEFT/RIGHT) DNS 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, THE EFFECTIVE THERAPY WAS ESTABLISHING VIA REPROGRAMING.
Patient problems: Movement Disorder
MAUDE report 25613039 ↗InjuryJun 15, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RETURNING SYMPTOMS DUE TO HIGH IMPEDANCES. 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: Movement Disorder
MAUDE report 25510682 ↗InjuryJun 10, 2026Break
IT WAS REPORTED THAT EXTENSION WIRE WAS FRAYED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: Movement Disorder
MAUDE report 25462276 ↗InjuryJun 5, 2026High impedance
IT WAS REPORTED THAT DURING AN IPG REPLACEMENT PROCEDURE IMPEDANCE CHECK REVEALED HIGH IMPEDANCE. AS SUCH, THE EXTENSION WAS EXPLANTED AND REPLACED ADDRESSING THE ISSUE. THERAPY WAS CONFIRMED POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25413223 ↗InjuryMay 27, 2026Fracture
IT WAS REPORTED THAT THE PATIENT'S RIGHT LEAD EXTENSION WAS FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD EXTENSION WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25303737 ↗InjuryMay 17, 2026Impedance Problem
IT WAS REPORTED THAT THE PATIENT'S EXTENSION HAD INVALID IMPEDANCES DUE TO THE PATIENT TWIDDLING WITH THE EXTENSION. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE EXTENSION WAS EXPLANTED AND REPLACED.
Patient problems: Twiddlers Syndrome
MAUDE report 25196684 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT THE IPG AND EXTENSION SITES. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 24865249 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT THE IPG AND EXTENSION SITES. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 24865049 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION INDICATES THE INFECTION HAS RESOLVED.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 24822784 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD AND EXTENSION SITES AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 24822739 ↗InjuryApr 8, 2026High impedance
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO REPLACE A NORMAL EOL IPG AN EXTENSION WAS FOUND TO HAVE HIGH IMPEDANCE SO THE PHYSICIAN REPLACED THE EXTENSION AS WELL TO MAKE SURE SYSTEM WAS COMPLETE AND CAPABLE OF MRI IF NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815698 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD REDUCED WOUND HEALING AT THE POCKET SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG AND EXTENSIONS WERE EXPLANTED.
Patient problems: Fluid Discharge
MAUDE report 24750776 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD REDUCED WOUND HEALING AT THE POCKET SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG AND EXTENSIONS WERE EXPLANTED.
Patient problems: Fluid Discharge
MAUDE report 24750775 ↗InjuryMar 30, 2026High impedance
IT WAS REPORTED THAT THE PATIENT'S RIGHT LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE EXTENSIONS WERE EXPLANTED AND REPLACED, RESOLVING THE IMPEDANCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24722955 ↗
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-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.
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
- 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 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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