NA DB-3216-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729966395), received between Jul 4, 2025 and Aug 6, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “High impedance” (3 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 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.

• InjuryAug 6, 2026Fracture; High impedance; Migration

  It was reported that the patient experienced inadequate stimulation. The patient had a history of falls attributed to orthostatic hypotension associated with Parkinson's disease. The treating physician suspected that a fall may have damaged the Deep Brain Stimulation (DBS) system. As part of the investigation, a surgical exploration was performed at the implantable pulse generator (IPG) pocket. Upon examination, it was observed that the suture loops securing the IPG had broken, the IPG had rotated within the pocket, and the extensions were visibly fractured and twisted. The physician also explored the intermediate incision site and removed the damaged extensions. New extensions were tunneled and connected to the existing leads and IPG. Following reconnection, impedance measurements were within normal limits, and the system was confirmed to be fully operational with no damage identified in the leads or IPG. Postoperatively, the patient was returned to the pre-existing stimulation settings and discharged following the outpatient procedure. The explanted devices will not be returned for analysis, as they were disposed of.

  Patient problems: Shaking/Tremors

  MAUDE report 50168278 ↗
• InjuryJul 31, 2026High impedance

  It was reported that the deep brain stimulation (DBS) patient underwent a surgical procedure to clean and restore the area above the ear where the wound incision reopened and the lead extension became exposed. Additionally, there were high impedances discovered on a few contacts. The physician believes the cause of the wound reopening was due to how the incision was closed by the physicians assistant, or that this model of lead extension is stiffer than an earlier model. The patient was doing well postoperatively.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 50101821 ↗
• InjuryJul 14, 2026High impedance

  IT WAS REPORTED THAT DURING THE STAGE TWO IMPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION (DBS) HIGH IMPEDANCES WERE OBSERVED ON FIVE CONTACTS. MULTIPLE ATTEMPTS WERE MADE TO RESOLVE THE IMPEDANCES, SUCH AS DISCONNECTING AND RECONNECTING THE LEAD EXTENSION FROM THE LEAD HOWEVER THE IMPEDANCES CONTINUED. THEREFORE, IT WAS DECIDED TO SWITCH OUT THE LEAD EXTENSION WITH A NEW LEAD EXTENSION. HOWEVER, THE HIGH IMPEDANCES CONTINUE ON ONE OF THE CONTACTS, AND IT WAS DETERMINED THAT HIGH IMPEDANCES WERE ON THE LEFT LEAD AND NOT THE LEAD EXTENSION. THE PHYSICIAN ASSESSED THAT THE IMPEDANCES MAY HAVE BEEN TISSUE RELATED, THAT THERE MAY BE AN AIR BUBBLE IN THE BRAIN, HOWEVER THIS WAS NOT CONFIRMED. THE PROCEDURE WAS PROLONGED AND ULTIMATELY COMPLETED, THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT BEYOND STANDARD OF CARE AND WAS DISCHARGED THE FOLLOWING DAY AND IS DOING WELL POST OPERATIVELY. IT IS UNCLEAR AS TO WHICH OF THE TWO IMPLANTED LEADS, WAS PLACED ON THE LEFT SIDE AND WAS EXHIBITING THE HIGH IMPEDANCES. IT IS ALSO UNCLEAR AS TO WHICH OF THE TWO LEAD EXTENSIONS WAS ULTIMATELY IMPLANTED AND WHICH WAS DISCARDED BY THE FACILITY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pneumocephalus

  MAUDE report 25808847 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION BEHIND THE RIGHT EAR AT THE LEAD EXTENSION INCISION SITE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. IT WAS NOTED THAT THERE WAS PUS AND THE WOUND SITE WAS OPEN. THE PATIENT ADMITTED TO PICKING AT THE INCISION SITE, WHICH IS THOUGHT TO BE THE CAUSE OF THE INFECTION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE TWO LEAD EXTENSIONS WERE EXPLANTED, WAS PLACED ON ANTIBIOTICS, AND IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Bacterial Infection; Fluid Discharge; Wound Dehiscence

  MAUDE report 25225951 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AT THE EXTENSION SITE WHERE IT CONNECTS TO THE LEAD, RESULTING IN EXPOSURE OF THE LEAD EXTENSION. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WERE NOT RETURNED.

  Patient problems: Erosion

  MAUDE report 24769514 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT PRESENTED WITH DEHISCENCE AT THE LEAD EXTENSION INCISION SITE BEHIND THE EAR. IT WAS NOTED THAT THE INCISION WAS NOT HEALING PROPERLY. THE PATIENT UNDERWENT INTERVENTION WHEREIN THE INCISION SITE WAS CLEANED WITH IODINE AND TREATED WITH ANTIBIOTICS BEFORE COMPLETING THE PROCEDURE. THE LEAD EXTENSIONS REMAIN IMPLANTED. IT IS UNCLEAR WHETHER CULTURES WERE OBTAINED. THE PATIENT WAS PLACED ON A REGIMEN OF STEROIDS AND ANTIBIOTICS AND HAS SINCE DEVELOPED A SCAB. ONGOING CARE IS BEING PROVIDED BY THE TREATING PHYSICIAN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED PAIN AND PURULENT DISCHARGE AT THE INCISION SITE. THE PATIENT IS DOING WELL AND WOUND HAS SINCE THEN CLOSED.

  Patient problems: Impaired Healing; Localized Skin Lesion; Pain; Purulent Discharge; Wound Dehiscence

  MAUDE report 23824067 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A FALL WHERE SHE BUMPED HER HEAD CAUSING A LACERATION NEAR THE LEAD EXTENSION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED TO AVOID ANY POSSIBLE RISK OF INFECTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED.

  Patient problems: Fall

  MAUDE report 23535384 ↗
• InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE INVOLVING COMPLETE REMOVAL OF THE DBS SYSTEM DUE TO INFECTION. THE PATIENT EXHIBITED FLUID DISCHARGE AT THE EXTENSION SITE. THE PATIENT REMAINS IN RECOVERY, AND ANTIBIOTIC THERAPY WAS INITIATED TO MANAGE THE INFECTION. THE HOSPITAL HAS RETAINED THE EXPLANTED DEVICES, AND THEY WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 22405274 ↗

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