St. Jude Medical Infinity™ DBS System (REF 6173)Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 05415067020697), received between Jun 14, 2018 and Apr 14, 2026 — classified as 93 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (32 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Malposition of Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED THAT THE RIGHT LEAD WAS NOT IMPLANTED IN THE PROPER LOCATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 24877750 ↗
• InjuryFeb 6, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A RETURN OF SYSTEMS, TREMORS. AS A RESULT, ON (B)(6) 2026 ADDITIONAL LEADS WERE PLACED BILATERALLY WITH STN PLACEMENT. THE EXISTING VIM LEADS ARE STILL IN PLACE AND IN USE. EFFECTIVE THERAPY WAS RESTORED. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 24283062 ↗
• InjuryJan 13, 2026Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED FOR SURGICAL INTERVENTION FOR A BILATERAL LEAD REVISION FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information; Movement Disorder

  MAUDE report 24058049 ↗
• InjuryJan 13, 2026Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026, WHEREIN BOTH LEADS WERE REPOSITIONED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; Movement Disorder

  MAUDE report 24058011 ↗
• InjuryOct 24, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT EXPERIENCED INSUFFICIENT PAIN RELIEF FROM THE DBS SYSTEM. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH LEAD ATTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 23383113 ↗
• InjuryJul 28, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT PATIENTS LEAD WAS IMPROPERLY PLACED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 22638269 ↗
• InjuryMar 3, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO LEFT LEAD PLACEMENT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Movement Disorder

  MAUDE report 21511042 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF SPEECH WHEN STIMULATION IS TURNED ON. THE ISSUE IS RESOLVED WHEN STIMULATION IS TURNED OFF. NO FURTHER INTERVENTION IS PLANNED AT THIS TIME.

  Patient problems: Speech Disorder

  MAUDE report 20901480 ↗
• InjuryOct 16, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 IN WHICH ANOTHER LEAD WAS ADDED, RESOLVING THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 20467878 ↗
• InjuryApr 1, 2024Therapeutic or Diagnostic Output Failure; Migration; Therapeutic or Diagnostic Output Failure; Migration

  IT WAS REPORTED THAT PATIENT EXPERIENCED INVOLUNTARY MOVEMENT. REPOSITIONING THE LEAD ON (B)(6) 2023 DID NOT RESOLVE THE ISSUE. IT WAS CONFIRMED VIA CT-SCAN THAT THE LEFT LEAD HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 19016501 ↗
• InjuryOct 12, 2023Fracture; High impedance; Fracture; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04531. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04537. IT WAS REPORTED THAT THE PATIENT¿S LEFT LEAD/EXTENSION WAS SHOWING HIGH IMPEDANCE RESULTING IN DECREASE ON THERAPY STRENGTH ON ITS OWN. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHERE IN THE EXTENSION WAS EXPLANTED AND REPLACED WITH NEW EXTENSION TO ADDRESS THE ISSUE. HOWEVER, THE LEFT LEAD STILL SHOWED HIGH IMPEDANCE. REPORTEDLY, AFTER TROUBLESHOOTING IT WAS DETERMINED THAT THE LEFT LEAD IS FRACTURED. HOWEVER, THE AUTO REDUCING ISSUE HAS BEEN STOPPED FOLLOWING THE EXTENSION REPLACEMENT. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS IS RIGHT OR LEFT LEAD.

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 17921402 ↗
• InjuryOct 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04844. IT WAS REPORTED THAT SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE PATIENTS LEADS WERE EXPLANTED AND REPLACED FOR AN UNKNOWN REASON ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17916580 ↗
• InjuryOct 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04845. IT WAS REPORTED THAT SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE PATIENTS LEADS WERE EXPLANTED AND REPLACED FOR AN UNKNOWN REASON ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17909272 ↗
• InjuryOct 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04838. IT WAS REPORTED THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE LEADS WERE REPOSITIONED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17909080 ↗
• InjuryOct 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6)2023 WHEREIN THE LEADS WERE REPOSITIONED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17909002 ↗
• InjurySep 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE BURR HOLE CAP. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE BURR HOLE CAP AND LEAD WERE EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH BURR HOLE CAP ATTRIBUTED TO THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17762343 ↗
• InjurySep 1, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE PATIENT UNDERWENT A SURGICAL INTERVENTION WHEREIN THE PHYSICIAN REMOVED THE REMAINING PART OF A LEAD ON (B)(6) 2023. THE LEAD HAD PREVIOUSLY BEEN CUT DURING A SURGERY ON (B)(6) 2022 TO REMOVE THE LEAD AND BURR HOLE CAP DUE TO AN INFECTION (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04201, 1627487-2023-04202).

  Patient problems: Foreign Body In Patient

  MAUDE report 17674038 ↗
• InjurySep 1, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE PHYSICIAN REMOVED THE REMAINING PART OF A LEAD ON (B)(6) 2023. THE LEAD HAD PREVIOUSLY BEEN CUT AND LEFT BEHIND DURING THE REMOVAL OF A PRIOR SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17672469 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03829. A MEDWATCH FORM REFERENCE NUMBER MW5119307 WAS RECEIVED ON 19 JUL 2023 STATING THAT THE PATIENT HAD DIFFICULTY BREATHING AND WENT TO EMERGENCY ROOM. SCANS FROM THE EMERGENCY ROOM SUSPECTED AIR ENCASES THE LARYNGEAL STIMULATOR LEADS AND POSSIBILITY OF ABSCESS. PATIENT WAS HOSPITALIZED FOR OBSERVATION. FURTHER SCAN REVEALED SOME AIR TRACKING DOWN AROUND THE LEADS. THE POSSIBILITY OF ABSCESS WAS NOT CONFIRMED AND POST PROCEDURAL CHANGES WITH POSSIBILITY OF LEAD EROSION WAS REPORTED. INFORMATION INDICATES THAT PATIENT IS CURRENTLY TAKING ORAL ANTIBIOTIC. REPORTEDLY, THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Dyspnea; Skin Erosion

  MAUDE report 17546382 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03830. A MEDWATCH FORM REFERENCE NUMBER MW5119307 WAS RECEIVED ON 19JUL2023 STATING THAT THE PATIENT HAD DIFFICULTY BREATHING AND WENT TO EMERGENCY ROOM (ER). SCANS FROM THE ER SUSPECTED AIR ENCASES THE LARYNGEAL STIMULATOR LEADS AND POSSIBILITY OF ABSCESS. PATIENT WAS HOSPITALIZED FOR OBSERVATION. FURTHER SCAN REVEALED SOME AIR TRACKING DOWN AROUND THE LEADS. THE POSSIBILITY OF ABSCESS WAS NOT CONFIRMED AND POST PROCEDURAL CHANGES WITH POSSIBILITY OF LEAD EROSION WAS REPORTED. INFORMATION INDICATES THAT PATIENT IS CURRENTLY TAKING ORAL ANTIBIOTIC. REPORTEDLY, THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Dyspnea; Skin Erosion

  MAUDE report 17546376 ↗
• InjuryMay 10, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER:1627487-2023-02182. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023, WHEREIN THE PATIENT'S DBS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16906327 ↗
• InjuryMay 10, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER:1627487-2023-02181. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE PATIENT'S DBS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16906284 ↗
• InjuryJan 31, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE THERAPY FROM THEIR DBS SYSTEM. AS A RESULT, PATIENT IS EXPECTED TO UNDERGO A LEAD REVISION TO OPTIMIZE SYMPTOM RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16272313 ↗
• InjuryDec 15, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION FOR CONTROLLING TREMORS. THERE WERE NO HIGH, LOW, OR INVALID IMPEDANCES. X-RAYS WERE TAKEN AND DID NOT INDICATE FRACTURE OR ISSUES WITH INTEGRITY OF THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEFT DBS LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15992920 ↗
• InjuryDec 5, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15915757 ↗

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, Classified
  Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
• Z-2693-2017 · Jun 2, 2017 · Terminated
  Infinity 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 · Terminated
  Infinity 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 · Terminated
  Infinity 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-2696-2017 · Jun 2, 2017 · Terminated
  Infinity 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