Vercise™ Cartesia™ X DB-2203-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729966340), received between May 1, 2025 and Sep 28, 2026 — classified as 3 deaths, 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (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. 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Fracture; High impedance; Unexpected Therapeutic Results; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918200 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Arrest; Discomfort; Inflammation; Respiratory Insufficiency; Swelling/ Edema

  MAUDE report 50892488 ↗
• InjurySep 18, 2026Unexpected Therapeutic Results; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831206 ↗
• MalfunctionSep 18, 2026Fracture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825056 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced edema of the left lead, however, it is unknown as to when the edema started, but it was stated that it was just after his implant. The patient was seen in the hospital, and was initially diagnosed with a stroke, however after examination it was determined that the patient had not had a stroke. He did experience confusion, and recall difficulties, at which time he was diagnosed with edema, he was hospitalized and prescribed steroids and is improving daily. No devices will be returned as they all remain implanted.

  Patient problems: Confusion/ Disorientation; Memory Loss/Impairment; Swelling/ Edema

  MAUDE report 50230741 ↗
• InjuryAug 6, 2026High impedance; Use of Device Problem; Low impedance

  It was reported that during a routine Deep brain stimulation (DBS) lead placement procedure, a lead located in the left part of the brain, which had been implanted during a previous procedure, was found to present multiple low and high impedances. The doctor explored the connection between the left brain electrode and the extension wire and identified a physical issue, as the lead was positioned at a 90-degree angle at the junction where the lead plugs into the extension wire. The doctor stated that the lead must have been damaged during the initial implant. The doctor then proceeded to straighten the kinked left brain electrode; however, this had no effect on the abnormal impedance readings. As the routine procedure did not contemplate replacement of the damaged lead, the doctor decided not to replace it and instead perform the programming around those impedances.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168157 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE LEADS DUE TO EROSION IN THE SCALP ON BOTH SIDES. THE PATIENT SCALP WAS NOTED TO BE TOO THIN TO ACCOMMODATE BOTH LEADS ON ONE SIDE. THE LEADS AND LEAD EXTENSIONS WERE REMOVED DUE TO INFECTION IN CONSEQUENCE OF THE EROSION. CULTURES WERE TAKEN AND CONFIRMED THE PRESENCE OF STAPHYLOCOCCUS. AS A RESULT OF THE INFECTION, THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY. THE DEVICE WILL NOT BE RETURNED BY THE FACILITY FOR FURTHER ANALYSIS.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 25627528 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT THAT WAS IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM LEADS DURING THE STAGE ONE PROCEDURE PRESENTED TO THE HOSPITAL WITH SYMPTOMS, INCLUDING SHAKING AND A LOSS OF CONSCIOUSNESS, OF A SUSPECTED SEIZURE. AFTER THE INITIAL IMPLANT A POST PROCEDURE COMPUTERIZED TOMOGRAPHY SCAN (CT) WAS PERFORMED AND NO ANOMALIES WERE NOTED. THE PHYSICIAN STATED THAT THE SYMPTOMS DID ALIGN WITH A SEIZURE, HOWEVER THAT IT WAS NOT ATTRIBUTED TO THE DBS DEVICES, BUT THAT THE CAUSE OF THE SEIZURE IS UNKNOWN. THE PATIENT WAS ADMITTED, AND ELECTROMYOGRAPHY (EMG) MONITORING WAS PERFORMED, AND WAS DOING WELL, THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL, AND THE STAGE TWO IMPLANT PROCEDURE WAS COMPLETED. NO DEVICES WILL BE RETURNED AS THEY ALL REMAIN IMPLANTED.

  Patient problems: Convulsion/Seizure; Loss of consciousness; Shaking/Tremors

  MAUDE report 25513842 ↗
• DeathJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PROCEEDED WITH THE IMPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. UPON COMPLETION OF THE INTERVENTION, THE PATIENT DEVELOPED A SUBDURAL HEMATOMA, WHICH SUBSEQUENTLY LED TO THE PATIENT'S DEATH. ACCORDING TO THE PHYSICIAN'S ASSESSMENT, THE PROCEDURE WAS DETERMINED TO HAVE CONTRIBUTED TO THE PATIENT'S COMPLICATION.

  Patient problems: Hematoma

  MAUDE report 25513172 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED CONFUSION, BALANCE ISSUES, AND DIFFICULTY FORMING SENTENCES. THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY DEPARTMENT. UPON EVALUATION, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A BRAIN ABSCESS LOCATED NEAR THE ANTERIOR LEFT-BRAIN ELECTRODE. THE PHYSICIAN NOTED THAT THE LEAD WAS NOT DIRECTLY WITHIN THE ABSCESS BUT POSITIONED A FEW MILLIMETERS POSTERIOR TO THE INFECTION. TO ADDRESS THIS, THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEFT BURR HOLE COVER AND TWO LEFT SIDED LEADS WERE EXPLANTED. DURING THE PROCEDURE, CULTURE SAMPLES WERE COLLECTED, THE INCISION SITE WAS IRRIGATED, AND THE HEAD INCISION WAS CLOSED. THE PATIENT WAS KEPT UNDER OBSERVATION OVERNIGHT. THE FOLLOWING DAY, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO DRAIN THE ABSCESS. THE PHYSICIAN REOPENED THE LEFT CRANIAL INCISION, DRAINED THE ABSCESS, AND CLOSED THE SITE. THE PATIENT WAS ADMITTED TO AN INPATIENT ROOM FOR MONITORING AND WAS REPORTED TO HAVE BEEN STARTED ON ANTIBIOTIC MEDICATION. SIX DAYS AFTER THE INITIAL PROCEDURE, IN WHICH TWO LEADS AND ONE BURR HOLE COVER WERE EXPLANTED, A REPEAT SCAN REVEALED THAT THE INFECTION HAD SP

  Patient problems: Abscess; Bacterial Infection; Balance Problems; Confusion/ Disorientation; Speech Disorder

  MAUDE report 25295137 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT THE FIRST STAGE IMPLANT PROCEDURE DURING WHICH THEY BECAME UNRESPONSIVE WHEREIN THEIR EYES WERE OPEN BUT THE RIGHT SIDE WAS UNABLE TO MOVE. THE LEADS HAD BEEN IMPLANTED AT THAT POINT AND IT WAS DISCOVERED VIA COMPUTERIZED TOMOGRAPHY (CT) SCAN THAT THE PATIENT HAD A BRAIN BLEED. THEREFORE, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR AN EMERGENCY CRANIOTOMY FOR EVACUATION OF THE BRAIN BLEED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL.

  Patient problems: Intracranial Hemorrhage; Paralysis

  MAUDE report 25186960 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED FALLS AND CONFUSION DUE TO A HEMATOMA DISCOVERED IN THE SUBDURAL, LEFT PARIETAL TEMPORAL LOBE. THE PHYSICIAN SUSPECTS SMALL VESSELS WERE IMPACTED DURING THE LEFT BRAIN ELECTRODE INSERTION DURING THE DBS STAGE ONE IMPLANT PROCEDURE. THEREFORE, THE PATIENT WAS HOSPITALIZED AND UNDERWENT A SUBDURAL HEMATOMA EVACUATION PROCEDURE. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Confusion/ Disorientation; Fall; Hematoma

  MAUDE report 24933585 ↗
• InjuryApr 15, 2026Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT'S BRAIN LEAD APPEARED DEEPER IN THE BRAIN THAN AT THE TIME OF IMPLANT. A POSTOPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SCAN CONFIRMED THAT THE LEAD HAD MIGRATED 3-4 MM DEEPER INTO THE BRAIN. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS RELATED TO THE DEVICE OR STIMULATION DUE TO THE LEAD POSITION. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE. IT WAS INITIALLY SUSPECTED THAT THE RETAINING CLIP MIGHT HAVE BEEN OPEN; HOWEVER, UPON REVISION, THE EXISTING RETAINING CLIP WAS OBSERVED SECURING THE LEAD AS INTENDED. THE CLIP WAS RELEASED, THE LEAD WAS RETRACTED A FEW MILLIMETERS, AND THE ORIGINAL CLIP WAS RE-SECURED. AN ADDITIONAL METALLIC FIXATION DEVICE WAS THEN PLACED OVER THE BHC CAP AND SECURED TO THE SKULL WITH SCREWS (DEVICE TYPE/MANUFACTURER WAS NOT CONFIRMED). THE PATIENT IS DOING WELL POSTOPERATIVELY. DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS THEY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888495 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A BRAIN BLEED POSTOPERATIVELY FROM A SURGICAL PROCEDURE AND WAS THEREFORE HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU). A COMPUTERIZED TOMOGRAPHIC IMAGING WAS TAKEN AND THE PATIENT CONTINUES TO BE MONITORED. THE PATIENT WAS UNRESPONSIVE FOR SOME TIME HOWEVER, REMAINS RECOVERING IN THE HOSPITAL.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24847613 ↗
• InjuryMar 16, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) LEADS WERE NOT PLACED OPTIMALLY WHEN INITIALLY IMPLANTED RESULTING IN NO BENEFIT FROM THE THERAPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED.

  Patient problems: Shaking/Tremors

  MAUDE report 24612477 ↗
• InjuryMar 13, 2026Fracture; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION FROM THE LEAD OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT UNDERWENT A SURGERY IN WHICH IT WAS DETERMINED THAT THE LEAD IS FRACTURED. THE PATIENT IS PENDING A REPLACEMENT PROCEDURE. THE PATIENT STATED THAT MULTIPLE REPROGRAMMING SESSIONS WERE COMPLETED AND DID NOT RESOLVE THE FEELING OF INADEQUATE THERAPY, AND OVERSTIMULATION AT TIMES ON THE ONE SIDE OF THEIR BODY.

  Patient problems: Burning Sensation; Inappropriate Device Stimulation of Tissue; Movement Disorder; Undesired Nerve Stimulation

  MAUDE report 24599433 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A RIGHT SIDED BRAIN BLEED FOLLOWING THE DBS IMPLANT PROCEDURE. THEREFORE, THE PATIENT WAS HOSPITALIZED. THE PATIENT IS DOING WELL AND IS EXPECTED TO FULLY RECOVER. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24565451 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE AT THE LEAD/LEAD EXTENSION SITE WHERE A LEAD HAD PROTRUDED THROUGH THE SKIN. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THEIR DBS SYSTEM AND A CULTURE WAS TAKEN INTRAOPERATIVELY. DUE TO HOSPITAL POLICY, THE CULTURE RESULTS WERE UNABLE TO BE DISCLOSED TO BSC. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY AND THE PATIENT WAS PLACED ON ANTIBIOTIC MEDICATION. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER.

  Patient problems: Bacterial Infection; Perforation; Wound Dehiscence

  MAUDE report 24352005 ↗
• InjuryFeb 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION WITH REDNESS AT THE LEAD SITE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT WAS REFERRED TO EMERGENCY ROOM DEPARTMENT (ER), WAS SUBSEQUENTLY ADMITTED AND UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE DEVICES WERE EXPLANTED, THE AREA WAS WASHED OUT WITH SALINE INFUSED ANTIBIOTICS AND IS UNDERGOING TREATMENT TO RESOLVE THE INFECTION. CULTURES WERE TAKEN AND WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT WAS DISCHARGED AND IS RECOVERING WELL. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Bacterial Infection; Bruise/Contusion; Erythema

  MAUDE report 24341215 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) EXPERIENCED AN INFECTION AT THE SITE OF THE LEAD. THE PATIENT WENT TO THE HOSPITAL AND UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED. A CULTURE WAS TAKEN AND RESULTS WERE NEGATIVE.

  Patient problems: Bacterial Infection

  MAUDE report 24153187 ↗
• InjuryDec 29, 2025High impedance; Difficult to Insert; Unexpected Therapeutic Results; High impedance; Difficult to Insert; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EVALUATED IN CLINIC FOR DEVICE REPROGRAMMING DUE TO RECURRENCE OF TREMOR IN THE RIGHT HAND. HIGH IMPEDANCE MEASUREMENTS WERE OBSERVED DURING THE ASSESSMENT. THE PATIENT REPORTED EXPERIENCING SEVERAL FALLS, ONE OF WHICH REQUIRED A VISIT TO URGENT CARE. THESE INCIDENTS WERE NOT BELIEVED TO BE RELATED TO THE DBS DEVICE BUT MAY HAVE CONTRIBUTED TO THE IMPEDANCE ISSUE. IMAGING OF THE LEAD AND LEAD EXTENSION SITE REVEALED A MISALIGNMENT AT THE CONNECTION. THE SURGEON OPTED TO MANIPULATE THE EXTENSION CONNECTION THROUGH THE SKIN, UNDER X-RAY GUIDANCE. PROPER ALIGNMENT BETWEEN THE LEAD AND EXTENSION WAS CONFIRMED THROUGH IMAGING AND IMPEDANCE TESTING VIA THE IMPLANTABLE PULSE GENERATOR (IPG). FOLLOWING THE PROCEDURE, IMPEDANCE LEVELS WERE WITHIN NORMAL RANGE. THE PATIENT IS RECEIVING EFFECTIVE THERAPY WITH GOOD SYMPTOM CONTROL. THE PATIENT WAS DISCHARGED HOME AND CONTINUES TO DO WELL. NO DEVICE RETURN IS EXPECTED, AS THE DEVICE REMAINS IMPLANTED.

  Patient problems: Shaking/Tremors

  MAUDE report 23918953 ↗
• InjuryDec 9, 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 OF THE ENTIRE SYSTEM DUE TO INFECTION. THE PATIENT SUFFERED A VASOVAGAL SYNCOPE AT HOME, NOT RELATED TO STIMULATION OR THE DEVICE, AND SUSTAINED A HEAD INJURY AS A RESULT OF THE FALL. THE WOUND WAS LOCATED IN THE AREA OF THE LEAD/LEAD EXTENSION JUNCTURE AND SUBSEQUENTLY BECAME INFECTED. THE SYMPTOMS THE PATIENT EXPERIENCED INCLUDED REDNESS, SWELLING, AND FLUID DISCHARGE. THE PATIENT WAS PLACED ON AN ANTIBIOTIC REGIMEN; HOWEVER, THE SURGEON DETERMINED THAT EXPLANTATION OF THE DEVICE WAS NECESSARY. THE PATIENT IS RECOVERING NORMALLY FOLLOWING THE EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE HOSPITAL AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Bacterial Infection; Erythema; Fluid Discharge; Swelling/ Edema

  MAUDE report 23754015 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM LEAD A POST OPERATIVE COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED, IT WAS DETERMINED THAT THE LEAD WAS IMPLANTED 7-8 MM INFERIOR OF SUBTHALAMIC NUCLEUS (STN) TARGET. THE PATIENT UNDERWENT A REVISION PROCEDURE THE FOLLOWING DAY IN WHICH THE LEAD WAS RETRACTED 7 MM. THE PATIENT IS EXPECTED TO FULLY RECOVER. NO DEVICES WILL BE RETURNED AS THEY REMAIN IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723795 ↗
• DeathNov 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY, A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED AFTER THE IMPLANT OF THE DEEP BRAIN STIMULATION (DBS) LEADS NO ANOMALIES WERE DETECTED. THE CAUSE OF THE PATIENTS' DEATH IS NOT KNOWN, HOWEVER, IT WAS NOTED THAT THE PATIENTS' DEATH WAS NOT DEVICE RELATED AND HAD NOTHING TO DO WITH THE IMPLANT PROCEDURE. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507476 ↗
• InjuryNov 7, 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 GENERAL WEAKNESS, HEADACHES, SPEECH DISORDER AND CONFUSION ONE WEEK AFTER THE LEAD IMPLANT PROCEDURE AND WAS ADMITTED IN THE EMERGENCY DEPARTMENT (ED). A COMPUTED TOMOGRAPHY (CT) IMAGE A HEMORRHAGE AND LEAD EDEMA ALONG THE LEFT FRONTAL TRACT WITH A HEMATOMA MEASURING APPROXIMATELY 1.6 X 1.1 X 2.0 CM. THE PATIENT WAS TAKEN TO INTENSIVE CARE UNIT (ICU) WHEREIN SEVERAL DOSES OF TRANEXAMIC ACID (TXA) DOSES WERE ADMINISTERED, BEGAN KEPPRA FOR SEIZURE PROPHYLAXIS AND HYDROCODONE-ACETAMINOPHEN FOR PAIN. ADDITIONAL CT IMAGES REVEALED THE ISSUE WERE IN STABLE CONDITION AND THE PATIENT DEMONSTRATED IMPROVEMENT. THE PHYSICIAN ASSESSED A CASUAL RELATION TO THE DEVICE. THE PATIENT WAS DISCHARGED AND HAS FULLY RECOVERED.

  Patient problems: Confusion/ Disorientation; Headache; Hematoma; Intracranial Hemorrhage; Muscle Weakness/Atrophy; Pain; Speech Disorder; Swelling/ Edema

  MAUDE report 23501180 ↗

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