NA DB-3128-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729966371), received between Jan 10, 2025 and Jun 16, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “High impedance” (4 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 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.

• InjuryJun 16, 2025High impedance; Unexpected Therapeutic Results; Migration; High impedance; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED BODY FATIGUE, PAIN, INADEQUATE THERAPY ON THEIR LEFT TORSO AND FELT THE IMPLANTABLE PULSE GENERATOR (IPG) ROTATE IN POCKET SITE. FUNCTIONAL TESTING REVEALED A HIGH IMPEDANCE CONTACT THAT WAS REPROGRAMMED AROUND RESULTING WITH ADEQUATE THERAPY AND PATIENT SYMPTOMS RESIDING. THE PHYSICIAN ASSESSED THAT THE PATIENTS SYMPTOMS WERE EXACERBATED WHILE THE DBS THERAPY WAS ON HOWEVER RESIDED ONCE REPROGRAMMED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS REPOSITIONED AND SECURED IN THE POCKET SITE AND ADDITIONAL FUNCTIONAL TESTING CONFIRMED HIGH IMPEDANCE ON THE LEAD EXTENSION AS A RESULT WAS REPLACED WITH ANOTHER OF THE SAME MODEL BEFORE COMPLETING THE PROCEDURE. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Fatigue; Movement Disorder; Pain; Undesired Nerve Stimulation

  MAUDE report 22214311 ↗
• InjuryMar 31, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A SCHEDULED DEEP BRAIN STIMULATION (DBS) ELECTIVE PROCEDURE A HIGH IMPEDANCE WAS DISCOVERED DURING FUNCTIONAL TESTING ON CONTACTS E1 AND E2. ATTEMPTS TO CLEAR THE HIGH IMPEDANCES WAS PERFORMED, HOWEVER WERE UNSUCCESSFUL. THE PHYSICIAN REPLACED THE LEAD EXTENSION WITH ANOTHER OF THE SAME MODEL AS A RESULT ADDITIONAL FUNCTIONAL TESTING REVEALED THE HIGH IMPEDANCES HAD RESOLVED AND PROCEEDED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE NOTED FROM THE HIGH IMPEDANCE ISSUE. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734348 ↗
• MalfunctionMar 26, 2025Fracture; High impedance; Use of Device Problem; Fracture; High impedance; Use of Device Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE A FRAGMENTED PORTION OF A LEAD EXTENSION THAT WAS CONNECTED TO THE IMPLANTABLE PULSE GENERATOR (IPG). THE LEAD EXTENSION HAD SNAPPED AND FRACTURED WHILE ATTEMPTING TO REMOVE IT DUE TO HIGH IMPEDANCES DURING A PREVIOUSLY REPORTED REVISION (SEE MFR REPORT TW (B)(4) ) AND REMAINED IMPLANTED IN THE PATIENT. THE LEAD EXTENSION WAS SUCCESSFULLY EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE FRAGMENTED LEAD EXTENSION WAS DISPOSED BY THE HOSPITAL AND WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704307 ↗
• InjuryJan 10, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A NUMBER OF FALLS AND SUSTAINED A HEAD INJURY AFTER BEING IMPLANTED. IT WAS NOTED THAT THE HEAD INJURY WAS LIKELY THE CAUSE OF THE HIGH IMPEDANCES PER THE PHYSICIAN'S ASSESSMENT, HOWEVER NO STIMULATION ISSUES WERE NOTED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN AN OPERATING ROOM (OR) CABLE WAS JUST TO DETERMINE THE HIGH IMPEDANCE MEASUREMENT WAS ON THE LEAD AND/OR LEAD EXTENSION. THE LEAD EXTENSIONS WERE REPLACED WITH OTHERS OF THE SAME MODEL WHICH SHOWED THE IMPEDANCE WITHIN RANGE AND THE LEADS REMAINED IMPLANTED. THE PATIENT DID WELL POST-OPERATIVELY. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Fall; Head Injury

  MAUDE report 21123674 ↗

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