Vercise Genus™ DB-1416Recalls & reported problems

Summary

The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 08714729985020), received between Aug 9, 2021 and Sep 30, 2026 — classified as 6 deaths, 216 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (106 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 240 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Unexpected Therapeutic Results; Battery Problem

  Patient problems: Pain

  MAUDE report 50953251 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results; Use of Device Problem; Device Displays Incorrect Message; Wireless Communication Problem

  It was reported that during a non-Boston Scientific related procedure to implant a pacemaker the deep brain stimulation (DBS) implantable pulse generator (IPG) was damaged. It was indicated that the stimulation was not properly turned off before the procedure as they thought it had been. After the procedure was completed the IPG was unable to enter into pairing mode in order to turn the stimulation back on resulting in a return of tremors in the upper extremities. Attempts were made to establish a connection between the remote control (RC) and IPG but continued to receive communication error messages. Attempts were made to evaluate the IPG but were unsuccessful as communication could not be established between the clinician programmer (CP) and IPG. It was indicated that before the procedure began the sales representative misread the type of IPG model the patient was implanted with and suggested using a magnet to turn the device stimulation off to expedite the process and not cause any delays with the procedure. Upon doing so in pre-op the patient was asked if he felt the device stimulation turn off and he said yes and also exhibited tremor symptoms which led to the belief that the

  Patient problems: Shaking/Tremors

  MAUDE report 50857148 ↗
• InjurySep 21, 2026Battery Problem

  It was reported that the patient underwent a deep brain stimulation (DBS) implantable pulse generator (IPG) replacement due to end of life (EOL). No patient complications were reported. The patient's postoperative status was reported as expected with no complications. The explanted device was retained by the hospital and was not returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842550 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Deep Brain Stimulation (DBS) device was replaced due to an unknown reason. The location of the replaced device is unknown. Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790278 ↗
• InjurySep 14, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765205 ↗
• DeathSep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep brain stimulation (DBS) patient passed away. The cause of death is unknown. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737245 ↗
• InjurySep 9, 2026Battery Problem

  It was reported that the deep brain stimulation (DBS) patient underwent a revision procedure during which the non-rechargeable implantable pulse generator (IPG) was explanted and replaced with a rechargeable IPG because the IPG had reached near its end of service (EOS). The patient received the elective replacement indicator (ERI) message on the remote control. The explanted device was not returned as it was retained by the medical facility. The patient was doing well postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693707 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 50600343 ↗
• DeathSep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a deep brain stimulation (DBS) system passed away. The cause of death is unknown. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599425 ↗
• InjuryAug 18, 2026Battery 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 replaced device is unknown. Additional information has been requested; and will be provided as it becomes available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308199 ↗
• InjuryAug 14, 2026Battery Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's Deep Brain Stimulation (DBS) implantable pulse generator (IPG) reached Elective Replacement Indicator (ERI) status. No patient symptoms, adverse effects, or device malfunctions were reported. As part of the intervention, the IPG was replaced. Postoperatively, the patient's status was not reported. The explanted device will not be returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50245663 ↗
• InjuryJul 29, 2026Battery Problem

  It was reported that this Deep Brain Stimulation (DBS) device was replaced due to an Elective Replacement Indicator (ERI) notification. The patient is a high energy user, and no additional patient complications were reported. The patient was reported to be recovering well postoperatively. The explanted device was disposed of by the facility and was not returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070614 ↗
• InjuryJul 28, 2026Battery Problem

  It was reported that the Deep Brain Stimulation (DBS) implantable pulse generator (IPG) reached end of service (EOS). As part of the intervention, the IPG was replaced. Postoperatively, the patient was reported to have resumed therapy with the replacement IPG and was receiving stimulation as intended. The explanted device will not be returned for analysis, as it was retained and disposed of by the hospital in accordance with facility policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063893 ↗
• InjuryJul 21, 2026Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) DISPLAYING AN END OF SERVICE (EOS) MESSAGE. IT WAS NOTED THAT THE DEVICE DID NOT ACHIEVE ITS EXPECTED SERVICE LIFE BEFORE REACHING END OF LIFE. THE IPG WAS SUBSEQUENTLY EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE DOING WELL WITH NO COMPLICATIONS. PER FACILITY POLICY, THE EXPLANTED DEVICE WAS RETAINED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25899323 ↗
• InjuryJul 20, 2026Battery Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) DISPLAYING AN END OF SERVICE (EOS) MESSAGE, THE EXACT DATE IS UNKNOW. IT WAS NOTED THAT THE DEVICE DID NOT ACHIEVE ITS EXPECTED SERVICE LIFE BEFORE REACHING END OF LIFE. THE IPG WAS SUBSEQUENTLY EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE DOING WELL WITH NO COMPLICATIONS. PER FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883985 ↗
• InjuryJul 20, 2026Battery Problem

  It was reported that this Deep Brain Stimulation (DBS) device was explanted due to end of life (EOL). The device was retained by the facility and will not be returned for analysis. Postoperatively, patient was reported to be doing well.Additional information was received indicating that the patient's device had reached End of Life (EOL), resulting in battery shutdown. The device displayed both the Elective Replacement Indicator (ERI) and End of Battery Life (EOL) messages. The patient was reported to be a high-frequency user.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883961 ↗
• InjuryJul 11, 2026Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS AND UNDERWENT IPG REPLACEMENT. THE PHYSICIAN INDICATED THAT THE PATIENT'S STIMULATION SETTINGS WERE SUFFICIENTLY POWER-INTENSIVE AND MAY HAVE CONTRIBUTED TO EARLIER ERI NOTIFICATION. THEREFORE, THE IPG REPLACEMENT WAS NOT CONSIDERED TO BE RELATED TO A DEVICE MALFUNCTION OR DEFECT. THE PHYSICIAN ALSO EXPRESSED CONCERN THAT, ONCE THE IPG REACHES A CERTAIN REMAINING BATTERY VOLTAGE, THE REMAINING BATTERY CAPACITY MAY DECLINE RAPIDLY. POSTOPERATIVELY, THE PATIENT'S STATUS WAS NOT REPORTED. INFORMATION REGARDING RETURN OF THE EXPLANTED DEVICE FOR ANALYSIS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25789643 ↗
• InjuryJul 9, 2026Unexpected Therapeutic Results; Battery Problem

  IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE DUE TO THE DEVICE REACHING END OF SERVICE (EOS). THE PATIENT HAS LIMITED VERBAL COMMUNICATION AND EXHIBITED SYMPTOMS INCLUDING DIFFICULTY WITH MOBILITY AND STIFFNESS. POSTOPERATIVELY, THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS RETAINED BY THE FACILITY.

  Patient problems: Speech Disorder; Unspecified Musculoskeletal problem

  MAUDE report 25773605 ↗
• InjuryJul 6, 2026Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. FURTHER INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED IF IT BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728139 ↗
• InjuryJun 9, 2026Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO IPG MIGRATION TO THE ARM. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

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

  MAUDE report 25451642 ↗
• InjuryJun 2, 2026Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION THAT IMPACTED HIS BALANCE. THE PATIENT NEEDED A FOCUSED ULTRASOUND AND THEREFORE DECIDED TO UNDERGO AN EXPLANT PROCEDURE OF THEIR DBS DEVICE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Balance Problems

  MAUDE report 25368154 ↗
• InjuryJun 1, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO IT HAVING REACHED ITS END OF SERVICE (EOS) WHERE THE ELECTIVE REPLACEMENT INDICTOR (ERI) MESSAGE WAS DISPLAYED ON THE REMOTE CONTROL. THE PHYSICIAN BELIEVES THE IPG HAD SHORTENED LONGEVITY. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352735 ↗
• InjuryMay 21, 2026Battery Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE AFTER RECEIVING AN END OF LIFE (EOL) MESSAGE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED, AND ELECTROCAUTERY WAS USED DURING THE PROCEDURE. THE PATIENT WAS STABLE POST OPERATION. THE FACILITY DISCARDED THE DEVICE IN ACCORDANCE WITH ITS GUIDELINES AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25248291 ↗
• InjuryMay 19, 2026Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT THE REPLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221784 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186925 ↗

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