St. Jude Medical Infinity™ DBS System (REF 6170)Recalls & reported problems
St. Jude Medical, Inc. · 8CH Directional Lead, 30 cm, 0.5 · 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 is an implanted system used for parkinsonian tremor. The 226 reports mostly describe components assembled incorrectly, with a few reporting high electrical resistance in the leads. The reports include 22 injuries and no deaths. One recall, started in October 2018 and now closed, concerns lead electrodes that may be made of a different metal than specified.
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
- 226
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 226 adverse event reports that list this exact device (DI 05415067020635), received between Oct 28, 2018 and Dec 18, 2025 — classified as 22 injuries, 204 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (204 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 18, 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
- Component Misassembled204
- Adverse Event Without Identified Device or Use Problem10
- High impedance7
- Impedance Problem3
- Low impedance2
- Fracture1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- No Consequences Or Impact To Patient205
- Inadequate Pain Relief12
- Hematoma2
- Post Operative Wound Infection2
- Edema1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 226 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S EXTENSIONS, LEADS AND BURR HOLE COVERS WERE EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. THE INVESTIGATION DID NOT DETERMINE WHICH PRODUCTS ATTRIBUTED TO THIS ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 23843772 ↗InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN ASYMPTOMATIC POST-OPERATIVE SUBDURAL, INTRAPARIETAL, AND INTRAVENTRICULAR HEMATOMA. THE PATIENT HAD NO INTERVENTION PERFORMED AND IS NOW STABLE.
Patient problems: Hematoma
MAUDE report 19082757 ↗InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN ASYMPTOMATIC POST-OPERATIVE SUBDURAL, INTRAPARIETAL, AND INTRAVENTRICULAR HEMATOMA. THE PATIENT HAD NO INTERVENTION PERFORMED AND IS NOW STABLE.
Patient problems: Hematoma
MAUDE report 19082711 ↗InjuryDec 18, 2022Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06924. IT WAS REPORTED THE PATIENT¿S LEAD AND EXTENSION WERE BOTH REPLACED DUE TO HIGH IMPEDANCE AND A POSSIBLE FRACTURE. IT IS UNKNOWN IF THE LEAD OR EXTENSION WAS FRACTURED AT THIS TIME.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 16001673 ↗InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17062. IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE ON (B)(6) 2021, THE PATIENT EXPERIENCED A MILD SUBARACHNOID HEMORRHAGE AT THE LEFT FRONTAL SULCUS. THE PATIENT WAS ASYMPTOMATIC. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12546517 ↗InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THE PATIENT NOW HAS DISARTRY AND RIGHT FACIAL PALSY, WALKING INSTABILITY, AND WORSENING OF PARKINSONISM SYMPTOMS RESULTING IN HOSPITALIZATION.
Patient problems: Paralysis
MAUDE report 12515444 ↗InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15369. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15370. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15372. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15373. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT DUE TO PURULENT WOUND ON THE RIGHT FRONTAL, LEFT FRONTAL AND INTRACLAVICULAR. THE PATIENT WAS PREVIOUSLY TREATED WITH ANTIBIOTICS WHICH HEALED THE LEFT FRONTAL AND LEFT INTRACLAVICULAR WOUND. HOWEVER THERE WAS STILL A WOUND ON THE RIGHT FRONTAL. AS SUCH, THE EXTENSIONS AND IPG WERE EXPLANTED ON (B)(6) 2021. THE LEADS ARE LEFT IMPLANTED IN THE PATIENT. REPORTEDLY, THE INFECTION HAS RESOLVED.
Patient problems: Post Operative Wound Infection
MAUDE report 12126023 ↗InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15370. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15371. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15372. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15373. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT DUE TO PURULENT WOUND ON THE RIGHT FRONTAL, LEFT FRONTAL AND INTRACLAVICULAR. THE PATIENT WAS PREVIOUSLY TREATED WITH ANTIBIOTICS WHICH HEALED THE LEFT FRONTAL AND LEFT INTRACLAVICULAR WOUND. HOWEVER THERE WAS STILL A WOUND ON THE RIGHT FRONTAL. AS SUCH, THE EXTENSIONS AND IPG WERE EXPLANTED ON (B)(6) 2021. THE LEADS ARE LEFT IMPLANTED IN THE PATIENT. REPORTEDLY, THE INFECTION HAS RESOLVED.
Patient problems: Post Operative Wound Infection
MAUDE report 12124612 ↗InjuryFeb 8, 2021High impedance; High impedance
RELATED MANUFACTURER REPORT 1627487-2020-48515. RELATED MANUFACTURER REPORT 1627487-2021-01048. IT WAS REPORTED THAT HIGH IMPEDANCE ISSUE WAS OBSERVED ON THE LEADS. ONE EXTENSION WAS EXPLANTED ON (B)(6) 2021 PROCEDURE. HIGH IMPEDANCE ISSUE WAS STILL OBSERVED, AND LEAD DAMAGE WAS OBSERVED ON ONE OF THE LEADS. BOTH LEADS WERE EXPLANTED, AND NEW LEADS WERE IMPLANTED. IT IS UNKNOWN WHICH LEAD HAD A DAMAGE ISSUE THEREFORE BOTH LEADS ARE BEING REPORTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.
Patient problems: Inadequate Pain Relief
MAUDE report 11299126 ↗InjuryFeb 8, 2021High impedance; High impedance
RELATED MANUFACTURER REPORT 1627487-2020-48515. RELATED MANUFACTURER REPORT 1627487-2021-01049. IT WAS REPORTED THAT HIGH IMPEDANCE ISSUE WAS OBSERVED ON THE LEADS. ONE EXTENSION WAS EXPLANTED ON (B)(6) 2021 PROCEDURE. HIGH IMPEDANCE ISSUE WAS STILL OBSERVED, AND LEAD DAMAGE WAS OBSERVED ON ONE OF THE LEADS. BOTH LEADS WERE EXPLANTED, AND NEW LEADS WERE IMPLANTED. IT IS UNKNOWN WHICH LEAD HAD A DAMAGE ISSUE THEREFORE BOTH LEADS ARE BEING REPORTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.
Patient problems: Inadequate Pain Relief
MAUDE report 11299075 ↗InjuryDec 18, 2020Impedance Problem; Impedance Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-49020. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-49021. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-49022. IT WAS REPORTED THAT FOLLOWING A HEAD TRAUMA THE IMPEDANCE READINGS WERE OUT OF RANGE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 11037966 ↗InjuryDec 18, 2020Impedance Problem; Impedance Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-49019. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-49021. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-49022. IT WAS REPORTED THAT FOLLOWING A HEAD TRAUMA THE IMPEDANCE READINGS WERE OUT OF RANGE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 11037957 ↗InjuryNov 13, 2019Impedance Problem; Impedance Problem
RELATED MFR REPORT: 1627487-2019-12764. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INSUFFICIENT THERAPY FROM THE DBS SYSTEM. IN FOLLOW UP IN THE CLINIC, THE HEALTHCARE PROVIDER PERFORMED A SYSTEM IMPEDANCE TEST AND DISCOVERED HIGH/INVALID IMPEDANCE ON ONE OF THE LEAD CHANNELS. THE PATIENT'S DBS SYSTEM COULD NOT BE REPROGRAMMED TO RECAPTURE BENEFICIAL THERAPY. ADDITIONAL FOLLOW UP IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) FOR AN INTRAOPERATIVE MEASUREMENT WITH EXTERNAL DEVICES. THE RESULTS WERE THE SAME AS BEFORE WITH THE INVALID IMPEDANCE FOR THE LEAD'S CHANNEL 1. THE DR. RECONNECTED THE INITIAL IPG WITH THE EXTENSIONS WITHOUT EXCHANGING ANY IMPLANTED PRODUCT. ADDITIONAL SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE.
Patient problems: Therapeutic Response, Decreased
MAUDE report 9319500 ↗InjuryMar 6, 2019High impedance; Low impedance; High impedance; Low impedance
DEVICE 4 OF 5. REFERENCE MFR REPORT: 1627487-2019-03087. REFERENCE MFR REPORT: 1627487-2019-03088. REFERENCE MFR REPORT: 1627487-2019-03089. REFERENCE MFR REPORT: 1627487-2019-03092.
Patient problems: Inadequate Pain Relief
MAUDE report 8396392 ↗InjuryMar 6, 2019High impedance; Low impedance; High impedance; Low impedance
DEVICE 5 OF 5. REFERENCE MFR REPORT: 1627487-2019-03087. REFERENCE MFR REPORT: 1627487-2019-03088. REFERENCE MFR REPORT: 1627487-2019-03089. REFERENCE MFR REPORT: 1627487-2019-03090.
Patient problems: Inadequate Pain Relief
MAUDE report 8396377 ↗InjuryMar 4, 2019High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCE ON THEIR LEAD SINCE IMPLANT. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN TO REPLACE THE LEAD.
Patient problems: Inadequate Pain Relief
MAUDE report 8386611 ↗InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FOLLOW UP INFORMATION RECEIVED IDENTIFIED THE EDEMA ISSUE PERSISTS, BUT IT DOES NOT CAUSE ANY PROBLEMS. THE ISSUE IS CONSIDERED RESOLVED.
Patient problems: Edema
MAUDE report 8334004 ↗InjuryDec 26, 2018High impedance; High impedance
DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2018-13385. IT WAS REPORTED DIAGNOSTICS INDICATED HIGH IMPEDANCE READINGS FOR BOTH DBS LEADS AND THE LEFT SIDED DBS LEAD WAS NOT OPTIMALLY PLACED. SURGERY WAS UNDERTAKEN AND BOTH LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 8195894 ↗InjuryDec 26, 2018High impedance; High impedance
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2018-13386. IT WAS REPORTED DIAGNOSTICS INDICATED HIGH IMPEDANCE READINGS FOR BOTH DBS LEADS AND THE LEFT SIDED DBS LEAD WAS NOT OPTIMALLY PLACED. SURGERY WAS UNDERTAKEN AND BOTH LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 8195888 ↗InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S (B)(6) LEAD HAD BEEN INCORRECTLY PLACED. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED WITH TWO NEW LEADS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8182799 ↗MalfunctionNov 14, 2018Component Misassembled; Component Misassembled
THE RECORD IS BEING PROACTIVELY INITIATED BASED ON THE ACKNOWLEDGED IMPLANTED OR UNKNOWN STATUS WHICH WAS IN RESPONSE TO THE MEDICAL DEVICE RECALL REMOVAL ACTIVITY, LETTER DATED 11OCT2018. THE LISTED SERIAL NUMBER FOR THE INFINITY DBS (DEEP BRAIN STIMULATION) LEAD MAY CONTAIN AN ELECTRODE THAT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8069142 ↗MalfunctionNov 13, 2018Component Misassembled; Component Misassembled
THIS RECORD IS BEING PROACTIVELY INITIATED BASED ON THE ACKNOWLEDGED IMPLANTED OR UNKNOWN STATUS WHICH WAS IN RESPONSE TO THE MEDICAL DEVICE RECALL REMOVAL ACTIVITY, LETTER DATED OCT 11, 2018. THE LISTED SERIAL NUMBER FOR THE INFINITY DBS (DEEP BRIAN STIMULATION) LEAD MAY CONTAIN AN ELECTRODE THAT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8067237 ↗MalfunctionNov 13, 2018Component Misassembled; Component Misassembled
THIS RECORD IS BEING PROACTIVELY INITIATED BASED ON THE ACKNOWLEDGED IMPLANTED OR UNKNOWN STATUS WHICH WAS IN RESPONSE TO THE MEDICAL DEVICE RECALL REMOVAL ACTIVITY, LETTER DATED OCT 11, 2018. THE LISTED SERIAL NUMBER FOR THE INFINITY DBS (DEEP BRAIN STIMULATION) LEAD MAY CONTAIN AN ELECTRODE THAT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8064710 ↗MalfunctionNov 12, 2018Component Misassembled; Component Misassembled
THIS RECORD IS BEING PROACTIVELY INITIATED BASED ON THE ACKNOWLEDGED IMPLANTED OR UNKNOWN STATUS WHICH WAS IN RESPONSE TO THE MEDICAL DEVICE RECALL REMOVAL ACTIVITY, LETTER DATED (B)(6) 2018. THE LISTED SERIAL NUMBER FOR THE INFINITY DBS (DEEP BRAIN STIMULATION) LEAD MAY CONTAIN AN ELECTRODE THAT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8062657 ↗MalfunctionNov 12, 2018Component Misassembled; Component Misassembled
THIS RECORD IS BEING PROACTIVELY INITIATED BASED ON THE ACKNOWLEDGED IMPLANTED OR UNKNOWN STATUS WHICH WAS IN RESPONSE TO THE MEDICAL DEVICE RECALL REMOVAL ACTIVITY, LETTER DATED OCT 11, 2018. THE LISTED SERIAL NUMBER FOR THE INFINITY DBS (DEEP BRIAN STIMULATION) LEAD MAY CONTAIN AN ELECTRODE THAT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8062191 ↗
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-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-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
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 · each recall links to the FDA recall notice
- 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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