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

Summary

The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 05415067030337), received between Apr 11, 2019 and May 15, 2026 — classified as 5 deaths, 173 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (48 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 178 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 25179649 ↗
• InjuryApr 3, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD TO WAS REPLACED ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Movement Disorder

  MAUDE report 24779128 ↗
• InjuryMar 30, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN THE LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 24722247 ↗
• InjuryMar 30, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN A LEAD WAS ADDED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Movement Disorder

  MAUDE report 24717544 ↗
• InjuryMar 18, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 24630441 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT'S SYSTEM WAS INFECTED AT THE BURR HOLE AND IPG POCKET SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24381553 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT'S SYSTEM WAS INFECTED AT THE BURR HOLE AND IPG POCKET SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24381531 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE BURR HOLE CAP SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE BURR HOLE CAP AND RIGHT LEAD WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 24377086 ↗
• InjuryJan 26, 2026Use of Device Problem

  IT WAS REPORTED THE PHYSICIAN ACCIDENTALLY MOVED THE PATIENT'S LEAD AND THE PATIENT NO LONGER HAD EFFECTIVE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS REPLACED RESTORING THERAPY.

  Patient problems: Movement Disorder

  MAUDE report 24184441 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED INFECTION AT THE LEAD/EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025, WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. PATIENT WAS ADMINISTERED IV AND ORAL ANTIBIOTICS, AND THE INFECTION HAS RESOLVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23854379 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED INFECTION AT THE LEAD/EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025, WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. PATIENT WAS ADMINISTERED IV AND ORAL ANTIBIOTICS AND THE INFECTION HAS RESOLVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23854375 ↗
• InjuryDec 2, 2025High impedance; No Apparent Adverse Event; High impedance; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED INDICATES THERE WAS NO ALLEGATION AGAINST THE LEAD. AS SUCH, THE LEAD IS NO LONGER DEEMED REPORTABLE.

  Patient problems: Movement Disorder; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690376 ↗
• InjuryNov 17, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT HAD EXCESSIVE TREMORS IN THE RIGHT SIDE OF THE BODY. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEFT LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Movement Disorder

  MAUDE report 23575966 ↗
• InjuryNov 13, 2025Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT IS SCHEDULED FOR A LEAD REVISION FOR AN UNKNOWN REASON.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 23543383 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S RIGHT LEAD WAS EXPOSED. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SURGEON OPENED A NEW SKIN FLAP TO TUCK THE LEAD UNDER TO ADDRESS THE ISSUE. THERE WAS NO INFECTION.

  Patient problems: Erosion

  MAUDE report 23523910 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A STROKE AND WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT ASSOCIATED WITH THE ISSUE.

  Patient problems: Stroke/CVA

  MAUDE report 22946574 ↗
• InjuryAug 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED PATIENT'S RIGHT LEAD HAD HIGH IMPEDANCES AND WAS BENT AT THE TIP WHICH WAS FOUND DURING PERM IMPLANT ON (B)(6) 2025. THE PHYSICIAN BENT THE LEAD BACK MANUALLY. THE PROCEDURE WAS EXTENDED AS A RESULT. ISSUE WAS RESOLVED AND THERAPY WAS ESTABLISHED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916660 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE LEFT BURR HOLE CAP AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS TO ADDRESS THE ISSUE. THE INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 22791223 ↗
• InjuryAug 6, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 22730083 ↗
• InjuryJul 28, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS ORIGINALLY IMPLANTED TO ANTERIOR. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 IN WHICH THE LEAD WAS REPOSITIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628332 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD AN INFECTION AT THE LEAD SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AT AN UNKNOWN TIME WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22570262 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD AN INFECTION AT THE LEAD SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AT AN UNKNOWN TIME WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22570162 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EROSION ON THE RIGHT LEAD SITE AND BURR HOLE CAP. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE RIGHT SIDED SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Erosion

  MAUDE report 22542247 ↗
• InjuryJul 10, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION IN MANAGING HER TREMORS. AS SUCH, SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD RESULTED IN INEFFECTIVE STIMULATION.

  Patient problems: Movement Disorder

  MAUDE report 22472194 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT LEAD AND LEFT EXTENSION HAD ERODED THROUGH THE SKIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD AND EXTENSION WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Skin Erosion

  MAUDE report 22412790 ↗

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-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
• 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