N/A 6345Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734403245), received between Jun 19, 2025 and Sep 24, 2026 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 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 was undertaken on (b)(6) 2026 wherein the left extension was explanted and replaced to address the issue.

  Patient problems: Movement Disorder

  MAUDE report 50888368 ↗
• InjuryApr 7, 2026High impedance

  IT WAS REPORTED THAT THE IMPEDANCE CHECK REVEALED HIGH IMPEDANCE ON THE RIGHT SIDE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026, WHEREIN THE EXTENSION WAS REPLACED. HOWEVER, THE ISSUE WAS NOT RESOLVED. PATIENT WAS WITH NO THERAPY FROM THE RIGHT SYSTEM. AS SUCH, ADDITIONAL SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026, WHEREIN THE LEAD WAS EXPLANTED AND REPLACED ADDRESSING THE ISSUE. REPORTEDLY, THERAPY WAS RESTORED POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809378 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT BOTH EXTENSION SITES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED.

  Patient problems: Implant Pain

  MAUDE report 22619284 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE EXTENSION SITE. IT IS UNKNOWN WHICH EXTENSION IS AT FAULT. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 22291243 ↗

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-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-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-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.