NA NM-5312Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729820956), received between Aug 26, 2020 and Oct 24, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Charging Problem” (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 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.

• MalfunctionOct 24, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG WAS REPLACED. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT DID NOT UNDERGO AN IPG REVISION PROCEDURE. IT WAS CLARIFIED THAT THE PATIENTS' CHARGER WAS NOT FUNCTIONING AS INTENDED AND WAS REPLACED, THE PATIENTS' CHARGING DIFFICULTY WAS RESOLVED AND IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386543 ↗
• InjuryJan 12, 2024Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) WHEREIN CAUSING INADEQUATE STIMULATION. THE PATIENTS CHARGER WAS REPLACED, AND THE CHARGING ISSUES HAVE RESOLVED.

  Patient problems: Shaking/Tremors

  MAUDE report 18508606 ↗
• InjuryAug 26, 2020No Display/Image; Charging Problem; No Display/Image; Charging Problem

  IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE CHARGER WAS REPLACED WHICH RESOLVED THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10457145 ↗

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