NA DB-2201-30DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729836490), received between Jan 9, 2018 and Dec 30, 2024 — classified as 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Fracture; High impedance; Off-Label Use; Material Twisted/Bent; Fracture; High impedance; Off-Label Use; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) PROCEDURE FUNCTIONAL TESTING WAS PERFORMED AND A HIGH IMPEDANCE WAS NOTED ON THE RIGHT LEAD. ATTEMPTS TO RESOLVE THE IMPEDANCE ISSUE WAS PERFORMED HOWEVER WAS UNSUCCESSFUL. IT WAS NOTED THAT THE LEAD DISTAL CONTACT TIP WAS BENT-FRACTURED WHEN TUNNELING THE LEAD TO THE LEAD EXTENSION PER THE PHYSICIAN'S ASSESSMENT. THE PHYSICIAN OPTED REMOVE THE LEAD PRIOR TO THE DBS SYSTEM EVER BEING TURNED ON. PHYSICAL ANALYSIS OF THE DBS LEAD WAS NOT PERFORMED AS IT WAS RETAINED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043494 ↗
• 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 STIMULATION LEAD IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A PERIFOCAL ELECTRODE EDEMA. THE EDEMA WAS DIAGNOSED VIA COMPUTERIZED TOMOGRAPHY. IT WAS NOTED THAT THERE WERE NO INTRA-OPERATIVE CHALLENGES OR COMPLICATIONS DURING LEAD PLACEMENT. THE PATIENT HAD AN EXTENDED HOSPITAL STAY AND WAS ADMINISTERED MEDICATION. THE PATIENT STATUS HAS IMPROVED AND THERE IS NO FURTHER COURSE OF ACTION.

  Patient problems: Swelling/ Edema

  MAUDE report 16189276 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ONE OF THE LEADS HAD MIGRATED WHICH CAUSED PROTRUSION FROM THE SCALP. THEREFORE, THE PATIENT HAD A LEAD REVISION TO CORRECT THE LEAD PROTRUSION. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORT.

  Patient problems: Erosion

  MAUDE report 13239909 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH SUSPECTED INFECTION. HOWEVER, THE PHYSICIAN ASSESSED THAT THE PATIENT'S SYMPTOMS WERE DUE TO A SUSPECTED HYPERSENSITIVITY TO THE POLYURETHANE FOUND IN THE LEADS. TOPICAL HYDROCORTISONE WAS APPLIED AND ORAL PREDNISOLONE WAS PRESCRIBED. THE PATIENT'S SYMPTOMS HAD SUBSIDED, AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12278544 ↗
• InjuryDec 16, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE LEAD WAS NOT IN THE DESIRED TARGET AREA AND THE PHYSICIAN DECIDED TO EXPLANT THE EXISTING LEAD AND IMPLANT A NEW LEAD. THE CURRENT LOCATION OF THE EXPLANTED LEAD IS NOT KNOWN.

  Patient problems: No Code Available

  MAUDE report 11019637 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED DUE TO ONGOING HEADACHES INCREASING IN SEVERITY AND A CONTINUED INFECTION AT THE IPG SITE FOLLOWING AN IPG EXPLANT PROCEDURE, PREVIOUSLY REPORTED IN MFR# 3006630150-2018-01150. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE LEADS AND LEAD EXTENSIONS, AND WAS THEN DISCHARGED. THE PATIENT IS RECOVERING AND THE EVENT IS RESOLVING. THE EVENT WAS REPORTED AS BEING CAUSALLY RELATED TO THE PROCEDURE AND HARDWARE, LEADS AND IPG, AND NOT RELATED TO THE STUDY DEVICE STIMULATION. NO DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: Unspecified Infection

  MAUDE report 7487290 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT BANGED HIS HEAD. SCABS AND AN INFECTION APPEARED AT THE LEAD INSERTION SITE OF THE CRANIAL LEADS. THE PATIENT WAS HOSPITALIZED AND RECEIVED IV ANTIBIOTICS STARTING ON 10-APR-2017, FOR 6 WEEKS. THE PATIENT THEN UNDERWENT AN EXPLANT PROCEDURE WHERE THE CRANIAL LEADS AND LEAD EXTENSIONS WERE REMOVED ON (B)(6) 2017. THE INFECTION HAS RESOLVED AND THE PATIENT IS DOING WELL. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS NOT SEVERE AND IT IS UNKNOWN IF THE INFECTION WAS RELATED TO THE DEVICE OR THE PROCEDURE.

  Patient problems: Bacterial Infection; Head Injury

  MAUDE report 7332803 ↗
• InjuryJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A MODERATE GAIT DISTURBANCE. THE PATIENT WAS ADMITTED, ADMINISTERED MEDICATION AND THE DEVICE WAS REPROGRAMMED. THE EVENT HAS RESOLVED AND WAS ASSESSED AS NOT RELATED TO THE PROCEDURE OR TO THE DEVICE HARDWARE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7176598 ↗

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