St. Jude Medical Infinity™ DBS System (REF 6171)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067030313), received between Nov 3, 2020 and Jul 17, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “High impedance” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WOUND AT THE LEAD INCISION SITE WAS NOT HEALING. THE WOUND SHOWED HEALING DISTURBANCE WITH PERSISTENT CRUSTING AND WHITE-CREAMY DISCHARGE, SUGGESTING SKIN EROSION AND DELAYED HEALING. NO DEVICE OR DEEP TISSUE WAS EXPOSED. A LOCATE INFECTION AT THE LEAD SITE WAS SUSPECTED. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHEREIN A WOUND REVISION WAS PERFORMED WITH THE HELP OF AN ANTIBIOTIC MESH. PATIENT WAS ADMINISTERED ANTIBIOTICS MEDICATION TO TREAT THE ISSUE. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. REPORTEDLY, THE WOUND HAS HEALED.

  Patient problems: Fluid Discharge; Post Operative Wound Infection; Skin Erosion; Unspecified Infection

  MAUDE report 22535305 ↗
• InjuryJul 2, 2021High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15321. IT WAS REPORTED THAT PATIENT EXPERIENCED TINGLING SENSATION IN THE ARMS, JAW, AND NECK. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE ON MULTIPLE CONTACTS OF THE LEAD. SURGERY MAY OCCUR TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD HAS HIGH IMPEDANCE SO BOTH LEADS ARE BEING REPORTED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12112737 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIFOCAL HEMORRHAGE AT THE PATIENT'S RIGHT DBS LEAD SITE OCCURRED. THE PATIENT WAS ADMINISTERED MEDICATION AND THE ISSUE RESOLVED OVER TIME. CT SCAN RESULTS FURTHER CONFIRMED RESOLUTION.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10779390 ↗

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