Vercise™ PC DB-1140-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729984467), received between Jul 17, 2020 and Mar 16, 2026 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT RECEIVED THE END OF LIFE (EOL) MESSAGE FOR THEIR PRIMARY CELL IMPLANTABLE PULSE GENERATOR (IPG) AND IT WAS SUSPECTED THAT THERE WAS PREMATURE BATTERY DEPLETION HOWEVER, THIS WAS NOT CONFIRMED. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. THE EXPLANTED IPG WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613377 ↗
• InjuryAug 28, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION AND SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22912608 ↗
• InjuryAug 28, 2024Battery Problem; Adverse Event Without Identified Device or Use Problem; Battery 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 DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083184 ↗
• InjuryAug 13, 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 UNDERWENT A REPLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG) FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG REPLACEMENT WAS AN ELECTIVE REPLACEMENT. THE IPG HAD REACHED NORMAL END OF SERVICE AND THERE WERE NO DEVICE ISSUES. THE EXPLANTED IPG WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978216 ↗
• InjuryMar 6, 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 UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT DUE TO EROSION AT THE IPG SITE.

  Patient problems: Erosion

  MAUDE report 18852738 ↗
• InjurySep 19, 2023Unexpected Therapeutic Results; Battery Problem; Unexpected Therapeutic Results; Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION AND NOTICED AN INCREASE IN THEIR PARKINSONS SYMPTOMS WHERE THEY WENT FROM WALKING TO WHEELCHAIR BOUND. UPON INTERROGATION OF THE NON-RECHARGEABLE IMPLANTABLE PULSE GENERATOR (IPG) IT WAS DISCOVERED THAT IT HAD REACHED THE END OF SERVICE. THE PHYSICIAN ASSESSED THAT THE EVENT OCCURRED WHEN THE PATIENT HAD A NON-DEVICE RELATED SURGERY WITHOUT TURNING OFF THE IPG AND HE ASSESSED THAT THE ELECTROCAUTERY MAY HAVE DAMAGED THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

  Patient problems: Movement Disorder

  MAUDE report 17774317 ↗
• InjuryJul 26, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE, WHEREIN THE PRIMARY CELL IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED, DUE TO END OF LIFE. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17400214 ↗
• InjuryMar 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AGITATION WITH AGGRESSION, AND SUICIDAL IDEATION. THE PHYSICIAN ASSESSED THE EVENT TO HAVE A POSSIBLE RELATIONSHIP TO THE DEVICE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. ADDITIONALLY, THE PHYSICIAN NOTED THE PATIENT HAD A HISTORY OF ALZHEIMER'S DISEASE SINCE 2019.

  Patient problems: Suicidal Ideation; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 16483275 ↗
• MalfunctionAug 12, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ELECTIVE PROCEDURE TO REPLACE THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG), A PORTION OF THE IPG PORT PLUG WAS FOUND IN THE IPG POCKET SITE. THE PORT PLUG WAS REMOVED AND THE PATIENT WAS DOING WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15219779 ↗
• InjuryJan 13, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) WAS DEPLETED. THE PHYSICIAN HAS REQUESTED AN ANALYSIS TO DETERMINE IF THE BATTERY DEPLETION WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252744 ↗
• InjuryJan 3, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION CAUSING HIS PREEXISTING SYMPTOMS TO RETURN. SEVERAL REPROGRAMMING SESSIONS OF THE DEVICE SYSTEM WERE MADE BUT WERE NOT SUCCESSFUL. THE DEVICE DATABASE WAS ANALYZED, AND NO ANOMALIES WERE NOTED. THE PATIENT UNDERWENT AN IPG, IMPLANTABLE PULSE GENERATOR, AND LEAD EXTENSION REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR DEVICE ANALYSIS AS THEY WERE RETAINED BY THE FACILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13146284 ↗
• MalfunctionNov 26, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENTS DEEP BRAIN IMPLANTABLE PULSE GENERATOR IPG PREMATURELY ACTIVATED THE ELECTIVE REPLACEMENT INDICATOR ERI MODE AT 2.72 VOLTS. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS STABLE POSTOPERATIVELY. THE IPG HAS BEEN RETAINED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THE IPG WILL NOT BE RETURNED TO BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877925 ↗
• MalfunctionOct 14, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO PREMATURE BATTERY DEPLETION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637290 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIARRHEA SECONDARY TO CLOSTRIDIUM DIFFICILE (C. DIFF) AND WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN ASSESSED THE EVENT WAS A PATIENT CONDITION THAT WAS MODERATE IN SEVERITY AND UNLIKELY RELATED TO THE DEVICE.

  Patient problems: Bacterial Infection; Diarrhea; Insufficient Information

  MAUDE report 12070964 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS IPG BEGAN TO ERODE THROUGH THE SKIN. THE IPG WAS EXPLANTED AND NO INFECTION WAS FOUND, THE CAUSE OF THE EROSION IS UNKNOWN. TH PATIENT WAS GIVEN SYSTEMIC ANTIBIOTICS FOR 6 WEEKS. AN IPG WILL BE REIMPLANTED AT A LATER DATE.

  Patient problems: Pocket Erosion

  MAUDE report 10680310 ↗
• InjuryJul 30, 2020Unexpected Therapeutic Results; Low impedance; Device Displays Incorrect Message; Unexpected Therapeutic Results; Low impedance; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, THE IPG STOPPED FUNCTIONING AND HAD TO BE REPLACED. ONCE THE IPG WAS REPLACED, THE PATIENT WAS FINE.

  Patient problems: No Code Available

  MAUDE report 10347944 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES DURING STIMULATION. THERE WERE MULTIPLE ATTEMPTS TO REPROGRAM HOWEVER THAT DID NOT RESOLVE THE COMPLAINT. IN ADDITION, THE PHYSICIAN WAS CONCERNED ABOUT INFECTION AS THE PATIENT REPORTED SOME SWELLING IN HIS NECK. THE PATIENT UNDERWENT AN EXPLANT OF THE ENTIRE SYSTEM AND DURING THE SURGERY THE PHYSICIAN NOTED THERE WAS NO OVERT SIGN OF INFECTION. A LARGE PART OF WHY THE PHYSICIAN CHOSE TO EXPLANT THE PATIENT WAS DUE TO HIS CONCERN ABOUT INFECTION. CULTURES WERE TAKEN HOWEVER THE RESULTS WERE NEGATIVE. THE SWELLING IN THE PATIENT'S NECK HAS RESOLVED WITHOUT INTERVENTION. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED AT THE HOSPITAL.

  Patient problems: Headache; No Code Available; Unspecified Infection

  MAUDE report 10292005 ↗

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