Vercise Genus™ DB-1408Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729989752), received between Feb 15, 2022 and Sep 8, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Battery Problem” (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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026High impedance; Battery Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679936 ↗
• InjuryAug 6, 2026Battery Problem

  It was reported that the Deep Brain Stimulation (DBS) implantable pulse generator (IPG) entered End of Service Indicator (EUI) mode. As part of the intervention, the IPG was replaced. Postoperatively, the patient was reported to be at baseline clinical status, and impedance measurements were within functional limits. The explanted device will not be returned for analysis, as it was disposed of by the facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168159 ↗
• InjuryMar 10, 2026Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT THE PROCEDURE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) REACHING END OF BATTERY LIFE (EBL). IT WAS FURTHER NOTED THAT THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS RECEIVED PRIOR TO THE EBL MESSAGE. THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE DEVICE WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. THE PATIENT DID NOT EXPERIENCE ANY STIMULATION ISSUES. POSTOPERATIVELY, THE PATIENT REMAINED AT BASELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562925 ↗
• InjuryDec 11, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A SHOCKING SENSATION IN HER BACK THAT WENT DOWN THE LEFT LEG DURING THE ANESTHESIA SPINAL TAP PORTION OF A NON-BSC DEVICE RELATED HIP REPLACEMENT PROCEDURE. THE PATIENT WAS HOSPITALIZED DUE TO THE SHOCKING PAIN. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED AFTER INTERROGATION OF THE DBS SYSTEM THERE WAS NO EVIDENCE FOUND THAT THE DEVICE CAUSED THE SHOCKING PAIN OR HOSPITALIZATION.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 23783899 ↗
• InjuryNov 6, 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 A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED WITH A DIFFERENT MODEL FOR AN UNKNOWN REASON. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486438 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DBS IMPLANTABLE PULSE GENERATOR (IPG) WAS ELECTIVELY REPLACED. THE IPG WAS RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS STABLE WITH THE REPLACEMENT IPG FUNCTIONING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23230152 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804967 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) SYSTEM WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730894 ↗
• InjuryMar 11, 2024Adverse 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 SEIZURE ON (B)(6) 2024 AND PRESENTED TO THE EMERGENCY ROOM (ER). ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE ER FOR A FALL. THE DBS SYSTEM WAS CONFIRMED TO BE OFF, AND IMPEDANCES WERE NORMAL. THE LEFT LEAD INCISION SITE APPEARED TO BE LEAKING CLEAR FLUID AND SOME BLOOD.

  Patient problems: Convulsion/Seizure; Fluid Discharge

  MAUDE report 18882545 ↗
• InjuryNov 14, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REPLACEMENT OF THE PRIMARY CELL IMPLANTABLE PULSE GENERATOR (IPG) DUE TO RECEIVING THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136150 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITE ON TOP OF THE LEAD EXTENSION AND LEAD CONNECTION SITE. THE AREA WAS RED, SWOLLEN, AND THERE WAS PUSS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM, IMPLANTABLE PULSE GENERATOR (IPG), LEADS AND LEAD EXTENSIONS WERE EXPLANTED, AND HE WAS PRESCRIBED ANTIBIOTICS. CULTURES WERE TAKEN AND CONFIRMED THERE WAS STAPHYLOCOCCUS AUREUS INFECTION. THE PHYSICIAN INDICATED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT IS NOT DOING WELL POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 16632753 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG, IMPLANTABLE PULSE GENERATOR, SITE AND INTERMEDIATE INCISION SITE. THE SITE WAS OBSERVED TO BE TENDER AND PUFFY WITH POSSIBLE FLUID ACCUMULATION DUE TO THE INFECTION. THE PATIENT UNDERWENT AN EXPLANT OF THEIR ENTIRE SYSTEM AND WAS PLACED ON ANTIBIOTICS FOR FOUR TO SIX WEEKS. THE PHYSICIAN STATED THAT THE INFECTION IS NOT DEVICE RELATED BUT THE CAUSE IS UNKNOWN. THE PATIENT IS DOING WELL.

  Patient problems: Bacterial Infection; Discomfort; Fluid Discharge

  MAUDE report 13539252 ↗

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