NA DB-3128-95Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729966388), received between Jul 3, 2025 and Nov 20, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “High impedance” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (P150031); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025High impedance; Appropriate Device Problem Term/Code Not Available; High impedance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A LOSS OF THERAPY AFTER AN ACCIDENT PLAYING FOOTBALL. THE PATIENT EXPERIENCED DYSTONIC MOVEMENTS IN THE ARM AND IN THE GAIT MOVEMENT ON THE RIGHT SIDE OF THE BODY. X-RAY IMAGING WAS PERFORMED AND CONFIRMED THE PRESENCE OF HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSION WAS REPLACED, AND THE HIGH IMPEDANCES RESOLVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Movement Disorder

  MAUDE report 23611409 ↗
• MalfunctionJul 3, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES CAUSED BY A FRACTURED LEAD EXTENSION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSION WAS REPLACED. AFTER REPLACING THE LEAD EXTENSION THERE WERE STILL HIGH IMPEDANCE MEASUREMENTS PRESENT. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CORRECT EVENT DATE OF THE HIGH IMPEDANCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150031. One submission often covers many models, so check the product and lot details in each record.

• Z-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• Z-2340-2025 · Jul 8, 2025 · Open, Classified
  Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
• Z-1890-2024 · Apr 18, 2024 · Open, Classified
  Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
• Z-2125-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the