NA DB-2201-30ACRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729820772), received between Jun 13, 2018 and Jan 17, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A DEEP BRAIN STIMULATOR (DBS) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED LARGE PERIFOCAL ELECTRODE EDEMA AND APATHY. THE EDEMA WAS DIAGNOSED VIA COMPUTERIZED TOMOGRAPHY. IT WAS NOTED THAT THERE WERE NO INTRA-OPERATIVE CHALLENGES OR COMPLICATIONS DURING LEAD PLACEMENT. THE PATIENT EXPERIENCED AN EXTENDED HOSPITAL STAY AND WAS ADMINISTERED CORDISONE. THE PATIENT STATUS HAS IMPROVED AND THERE IS NO FURTHER COURSE OF ACTION.

  Patient problems: Emotional Changes; Swelling/ Edema

  MAUDE report 16189599 ↗
• InjuryJun 13, 2018Fracture; High impedance; Fracture; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE THERAPY DUE TO HIGH IMPEDANCES. X-RAY REVEALED THAT THE CONNECTORS FOR THE LEFT AND RIGHT LEAD WERE SITUATED APART WITH ONE BEHIND THE RIGHT EAR AND ONE FURTHER DOWN THE NECK. THE PHYSICIAN DECIDED TO PERFORM AN EXPLORATORY SURGERY TO DETERMINE THE SOURCE OF THE IMPEDANCE. THE LEFT LEAD CONNECTOR WAS RECONNECTED TO THE LEAD EXTENSION. THE PHYSICIAN NOTICED THAT THE CONNECTOR FURTHER DOWN THE NECK HAD A SLIGHT DISCONTINUATION OF THE INSULATION ON THE LEAD. THE PHYSICIAN COULD SEE A FRACTURE OF THE LEAD, HOWEVER THERE WERE NO EXPOSED CABLES. THE PATIENT WILL UNDERGO A FULL LEAD REVISION.

  Patient problems: Bacterial Infection; Inadequate Pain Relief

  MAUDE report 7597216 ↗

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