NA DB-3128-95BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506023584), received between Apr 4, 2023 and Nov 29, 2023 — classified as 2 injuries.

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

• InjuryNov 29, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING THE SECOND STAGE IMPLANT PROCEDURE, THE PHYSICIAN CONNECTED THE NEW DEEP BRAIN STIMULATION LEAD TO THE PREVIOUSLY IMPLANTED LEAD EXTENSION AND MOST CONTACTS DISPLAYED HIGH IMPEDANCES. IT IS UNKNOWN IF THE ISSUE WAS PRESENT AT THE ORIGINAL IMPLANT STAGE OR CAUSED AT THIS SECOND STAGE IMPLANT PROCEDURE. HOWEVER, THE PHYSICIAN REPLACED THE LEAD EXTENSION WITH A NEW EXTENSION WHICH RESOLVED THE IMPEDANCES. THE ORIGINAL LEAD EXTENSION WAS CUT AT BOTH THE PROXIMAL AND DISTAL ENDS AND A PORTION REMAINS IN THE PATIENTS NECK. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD EXTENSION PORTIONS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230992 ↗
• InjuryApr 4, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING THE SECOND STAGE OF THE DEEP BRAIN STIMULATION IMPLANT PROCEDURE, WHEN THE ALREADY IMPLANTED LEAD EXTENSION WAS TO BE CONNECTED TO THE IPG, THIS LEAD EXTENSION WAS FOUND TO HAVE NOT BEEN COILED BEHIND THE EAR IN A WAY THAT MADE IT ACCESSIBLE DURING THE FIRST STAGE IMPLANT PROCEDURE. IN ADDITION, SCAR TISSUE BUILT AROUND THE LEAD BEHIND THE EAR IN THE TIME BETWEEN SURGERIES. THE PHYSICIAN REOPENED THE LEAD INCISION TO GET TO THE LEAD AND EXTENSIVELY MANIPULATED THE UNCOILED LEAD. THE LEAD EXTENSION WAS THEN TESTED AND DISPLAYED HIGH IMPEDANCES. THE PHYSICIAN REPLACED THE LONGER LEAD EXTENSION WITH A NEW SHORTER LEAD EXTENSION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Scar Tissue

  MAUDE report 16671358 ↗

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-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-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• 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