St. Jude Medical Infinity™ DBS System (REF 6372)Recalls & reported problems

Summary

The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 05415067020857), received between Jul 10, 2018 and Sep 22, 2026 — classified as 231 injuries, 6 malfunctions.

The most frequently reported specific device problem is “High impedance” (91 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 237 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862128 ↗
• InjuryAug 4, 2026Impedance Problem

  UIt was reported that the patient¿s extensions exhibited high impedances prior to the procedure. Patient was diagnosed with twiddler's syndrome. As a result, surgical intervention was undertaken wherein the extensions were untwisted and the IPG was replaced to address the issue.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50125715 ↗
• InjuryAug 4, 2026Impedance Problem

  It was reported that the patient¿s extensions exhibited high impedances prior to the procedure. Patient was diagnosed with twiddler's syndrome. As a result, surgical intervention was undertaken wherein the extensions were untwisted and the IPG was replaced to address the issue.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50125714 ↗
• InjuryAug 3, 2026Break; Use of Device Problem

  It was reported that during a normal EOL IPG replacement, the physician had a difficulty removing the extensions from the header. The leads broke causing high impedances. Surgical intervention may be pending to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50113420 ↗
• InjuryJul 27, 2026Fracture

  It was reported that the patient's leads exhibited high impedances due to damaged wires on both extensions. As a result, surgical intervention was undertaken on (b)(6)2026 to address the issue, wherein both extensions were explanted and replaced. Impedances cleared post-operatively.

  Patient problems: Movement Disorder

  MAUDE report 50045502 ↗
• InjuryJul 27, 2026Fracture

  It was reported that the patient's leads exhibited high impedances due to damaged wires on both extensions. As a result, surgical intervention was undertaken on (b)(6) 2026 to address the issue, wherein both extensions were explanted and replaced. Impedances cleared post-operatively.

  Patient problems: Movement Disorder

  MAUDE report 50045490 ↗
• InjuryJun 2, 2026High impedance

  IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361779 ↗
• InjuryFeb 2, 2026Low impedance

  SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026, WHEREIN THE PHYSICIAN REMOVED THE EXTENSION FROM THE HEADER, WIPED IT, SUCTIONED THE PORT AND REINSERTED THE EXTENSION IN TO THE HEADER TO ADDRESS THE ISSUE. PATIENT WAS PROGRAMMED POST-OP AND RECEIVING EFFECTIVE THERAPY.

  Patient problems: Movement Disorder

  MAUDE report 24239979 ↗
• InjuryJan 13, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON BOTH LEFT AND RIGHT EXTENSIONS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE EXTENSIONS WERE REPLACED; HOWEVER, IMPEDANCES REMAINED AFTER REPLACING EXTENSIONS.

  Patient problems: Movement Disorder

  MAUDE report 24050277 ↗
• InjuryJan 13, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON BOTH LEFT AND RIGHT EXTENSIONS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE EXTENSIONS WERE REPLACED; HOWEVER, IMPEDANCES REMAINED AFTER REPLACING EXTENSIONS.

  Patient problems: Movement Disorder

  MAUDE report 24050270 ↗
• InjuryDec 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT EXPERIENCED RETURN OF SYMPTOMS FOLLOWING A RECENT FALL. DIAGNOSTICS REVEALED IMPEDANCES. IT WAS ALSO REPORTED THAT THE EXTENSIONS WERE FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 23701431 ↗
• InjuryDec 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT EXPERIENCED RETURN OF SYMPTOMS FOLLOWING A RECENT FALL. DIAGNOSTICS REVEALED IMPEDANCES. IT WAS ALSO REPORTED THAT THE EXTENSIONS WERE FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 23701426 ↗
• InjuryNov 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THEIR LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 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 23639557 ↗
• InjuryNov 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THEIR LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 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 23639554 ↗
• InjuryNov 24, 2025High impedance; High impedance

  IT WAS REPORTED THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES AND UNABLE TO SET IPG TO MRI MODE. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXTENSION AND IPG WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23631924 ↗
• InjuryNov 18, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT EXTENSION HAD ABNORMAL IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE EXTENSION WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586433 ↗
• InjuryNov 11, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT EXTENSION HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE RIGHT EXTENSION WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526897 ↗
• InjuryOct 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON BOTH EXTENSIONS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED.

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

  MAUDE report 23430598 ↗
• InjuryOct 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON BOTH EXTENSIONS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED.

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

  MAUDE report 23430580 ↗
• InjuryAug 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION. IT WAS DETERMINED THAT THE PATIENT TWIDDLED BOTH OF THE IPGS RESULTING IN LEFT EXTENSION FRACTURED AND RIGHT EXTENSION WAS TWISTED. AS RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH IPGS AND BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22896338 ↗
• InjuryAug 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION. IT WAS DETERMINED THAT THE PATIENT TWIDDLED BOTH OF THE IPGS RESULTING IN LEFT EXTENSION FRACTURED AND RIGHT EXTENSION WAS TWISTED. AS RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH IPGS AND BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22896328 ↗
• InjuryAug 5, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT¿S THERAPY STRENGTH DECREASED ON ITS OWN. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON THE RIGHT SIDE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE EXTENSIONS HAD HIGH IMPEDANCES.

  Patient problems: Movement Disorder

  MAUDE report 22715398 ↗
• InjuryAug 4, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON LEFT CONTACT. IT IS UNCLEAR IF THE HIGH IMPEDANCES WERE PRESENT ON THE LEAD EXTENSION OR THE IPG. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHEREIN BOTH THE LEFT LEAD EXTENSION AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 22709981 ↗
• InjuryJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT¿S THERAPY STRENGTH WAS DECREASING ON ITS OWN. REPORTEDLY, PATIENT HAD SOME FALLS. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES. REPORTEDLY, PATIENT HAD SOME FALLS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEFT EXTENSION WAS EXPLANTED AND REPLACED ADDRESSING THE ISSUE. REPORTEDLY, THERAPY WAS RESTORED POST OP.

  Patient problems: Movement Disorder

  MAUDE report 22648901 ↗
• InjuryJul 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER:1627487-2025-03263) ON (B)(6) 2025, THE EXTENSION WIRES WERE DAMAGED AND INSERTING BOTH LEADS WAS DIFFICULT. IN TURN, THE RIGHT LEAD ONE LEIT WAS USED AND FOR THE LEFT LEAD FIVE LEITS WERE USED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585794 ↗

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-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-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