Vercise Genus™ DB-1232Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 08714729985051), received between Sep 2, 2021 and Sep 23, 2026 — classified as 2 deaths, 41 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (5 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 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.

Recalls naming this device

1. Jul 8, 2025Open, Classified

   Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

   Z-2558-2025 · Root cause: Labeling design · FDA record ↗

2. Apr 18, 2024Open, Classified

   Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

   Z-1890-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Convulsion/Seizure; Hematoma

  MAUDE report 50876109 ↗
• DeathSep 8, 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 50658899 ↗
• InjuryAug 17, 2026Charging Problem; Wireless Communication Problem

  It was reported that the deep brain stimulation (DBS) patient underwent an implant procedure to implant new leads however, prior to the procedure the patient experienced difficulty charging the implantable pulse generator (IPG) out of hibernation mode and thus the IPG would not communicate with the remote control. Therefore, this IPG was explanted from the abdomen and replaced with a new IPG that was placed in the chest subcutaneously. As the lead extensions were locked into the IPG and unable to be removed, they were cut and a portion of the lead extensions remain implanted. There were no reported patient complications and the patient is stable postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50284765 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Atrial Fibrillation; Convulsion/Seizure; Ischemia Stroke; Pneumonia; Sepsis; Shaking/Tremors; Unspecified Mental, Emotional or Behavioral Problem; Wound Dehiscence

  MAUDE report 50260541 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the deep brain stimulation (DBS) patient developed an infection around the site of the implantable pulse generator (IPG) a few weeks post implant procedure resulting in tenderness, heat, swelling and localized discomfort. The patient underwent a procedure where four syringes of fluid were removed from the IPG pocket site. The patient was placed on oral antibiotics which cleared the infection and the patient was doing well. Cultures were taken but the results were unavailable.

  Patient problems: Discomfort; Swelling/ Edema; Unspecified Infection

  MAUDE report 50256066 ↗
• DeathAug 5, 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 50145823 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A CONCENTRATION OF BLOOD, SWELLING AND SUSPECTED INFECTION AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSION IMPLANT SITE. IN THE PHYSICIANS OPINION THE PATIENTS SYMPTOMS WERE NOT DEVICE OR PROCEDURE RELATED, HOWEVER INDICATIONS ON THE POTENTIAL CAUSE WERE NOT PROVIDED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEAD EXTENSIONS WERE REMOVED BEFORE COMPLETING THE PROCEDURE. ANALYSIS OF THE DEVICES WAS PERFORMED AS THEY WERE DISPOSED BY THE FACILITY. THE PATIENT DID WELL POSTOPERATIVELY.

  Patient problems: Bacterial Infection; Hematoma; Swelling/ Edema

  MAUDE report 25283686 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSIONS DUE TO A SCAB AT THE LEAD EXTENSIONS SITE THAT WAS NOT HEALING. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, AND CULTURES WERE TAKEN, BUT THE RESULTS HAVE NOT BEEN DISCLOSED. POSTOPERATIVELY, THE PATIENT IS STABLE. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Impaired Healing

  MAUDE report 25236409 ↗
• InjuryMay 8, 2026Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SEIZURES DURING AND AFTER THE STAGE TWO IMPLANT PROCEDURE. HOSPITALIZATION WAS REQUIRED BEYOND THE STANDARD POST-OPERATIVE CARE. THE PATIENT WAS NONVERBAL FOLLOWING THE PROCEDURE, A CONDITION THAT HAD NOT BEEN PRESENT BEFOREHAND. DBS THERAPY HAD NOT YET BEEN INITIATED, AS THE PATIENT HAD BEEN GIVEN TIME TO HEAL. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IMPLANTED. SINCE THE EVENT, THE PATIENT RECOVERED. IT IS PLANNED THAT THE DBS DEVICE WILL BE SWITCHED AT AN UNDETERMINED TIME FOLLOWING A FUTURE FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN.

  Patient problems: Convulsion/Seizure; Speech Disorder

  MAUDE report 25124230 ↗
• InjuryApr 3, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH A DEEP BRAIN STIMULATION (DBS) TO TREAT PAIN, EXPERIENCED PAIN LOCALIZED AT THE IMPLANTABLE PULSE GENERATOR (IPG) CHEST INCISION SITE. PAIN MEDICATION WAS ADMINISTERED; HOWEVER, THE SYMPTOMS PERSISTED. THE PATIENT SUBSEQUENTLY UNDERWENT REMOVAL OF THE IPG AND LEAD EXTENSIONS PRIOR TO COMPLETION OF THE PROCEDURE. IN THE PHYSICIANS OPINION, THE INFECTION WAS PROCEDURE-RELATED AND ASSOCIATED WITH THE INCISION. DEVICE ANALYSIS WAS NOT PERFORMED, AS THE COMPONENTS WERE DISCARDED BY THE FACILITY. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WELL POSTOPERATIVELY.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 24780764 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE, ON THEIR CHEST, OF THE DEEP BRAIN STIMULATION (DBS) DID NOT HEAL ADEQUATELY AND DEVELOPED AN INFECTION, THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS HOSPITALIZED, UNDERWENT AN EXPLANT OF THE (IPG) AND THE LEAD EXTENSIONS, CULTURES WERE TAKEN, HOWEVER, THE RESULTS ARE UNKNOWN, AND THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 24492425 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT REPORTED DISCOMFORT, REDNESS, SWELLING, AND PURULENT DISCHARGE AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD INCISION SITES. THE PATIENT SUBSEQUENTLY UNDERWENT REMOVAL OF THE DBS SYSTEM. ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT ATTRIBUTED TO THE DEVICE OR THE PROCEDURE, THOUGH NO ALTERNATIVE CAUSE WAS PROVIDED. DEVICE ANALYSIS WAS NOT PERFORMED AS THE COMPONENTS WERE RETAINED BY THE MEDICAL FACILITY. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND MADE A FULL RECOVERY. GOOD-FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE.

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

  MAUDE report 24434612 ↗
• InjuryFeb 20, 2026Off-Label Use

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION NEAR THE RIGHT CHEST OVER THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY AND WERE NOT RETURNED. A CULTURE WAS TAKEN BUT THE RESULTS WERE NOT AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 24405862 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE BURR HOLE COVER INCISION SITE AND THE IMPLANTABLE PULSE GENERATOR (IPG) CHEST INCISION SITE. THE PATIENT EXPERIENCED SYMPTOMS OF SWELLING, REDNESS, AND PURULENT DISCHARGE DUE TO THE INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THERE WAS A CULTURE TAKEN BUT THE RESULTS WERE NOT RELEASED BY THE HOSPITAL. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED.

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

  MAUDE report 24367755 ↗
• InjuryFeb 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION, WITH REDNESS, BRUISING AND PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM, IT WAS ALSO NOTED THAT THE SKIN APPEARED TO BE FRAIL. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE IPG WAS 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 DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE FACILITY.IT WAS ADDITIONALLY REPORTED THAT THAT LEFT LEAD EXTENSION WAS EXPLANTED DURING THIS PROCEDURE.ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD ADDITIONAL SYMPTOMS OF SKIN IRRITATION OVER THE IPG AND THAT THERE WAS EROSION OF THE IPG.

  Patient problems: Bacterial Infection; Bruise/Contusion; Erythema; Implant Pain; Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 24341206 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION LEADING TO DEHISCENCE AT THE IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE. THE PHYSICIAN BELIEVED THE AREA WAS INFECTED, THOUGH THE INFECTION WAS NOT CONSIDERED RELATED TO THE DEVICE OR THE PROCEDURE. IT IS UNKNOWN WHETHER CULTURES WERE OBTAINED. THE PATIENT SUBSEQUENTLY UNDERWENT COMPLETE EXPLANTATION OF THE DBS SYSTEM BEFORE COMPLETING THE PROCEDURE. ANALYSIS OF THE DEVICES WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 24282973 ↗
• InjuryJan 20, 2026Unexpected Therapeutic Results; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A COMMUNICATION ERROR WITH THE IMPLANTABLE PULSE GENERATOR (IPG) AND A LOSS OF STIMULATION RESULTING IN A RETURN OF THEIR PRE-EXISTING TREMOR AFTER THEY UNDERWENT A CARDIOVERSION. THE CARDIOVERSION WAS PERFORMED AT 200 VOLTAGE AT THE RIGHT SHOULDER ABOVE THE IPG WHICH WAS TURNED OFF PRIOR TO THE PROCEDURE. AS SUCH, THE PHYSICIAN ASSESSED THE CARDIOVERSION MAY HAVE CONTRIBUTED TO THE COMMUNICATION DIFFICULTY AND LOSS OF STIMULATION. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Shaking/Tremors

  MAUDE report 24117407 ↗
• InjuryJan 13, 2026Nonstandard Device; Charging Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED NON-DEVICE RELATED HEART ISSUES WHEREIN DEFIBRILLATION WAS REQUIRED. THE DEFIBRILLATOR WAS PLACED DIRECTLY OVER THE IMPLANTABLE PULSE GENERATOR (IPG) DURING DEFIBRILLATION. APPROXIMATELY TWO WEEKS LATER IT WAS DETERMINED THAT THE IPG BATTERY WAS FRIED AND NEEDED TO BE REPLACED AS THE IPG WAS UNABLE TO HOLD ANY CHARGE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058174 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE IN THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. FOLLOWING A NON DEVICE RELATED INCIDENT, THE PATIENT SUSTAINED A LACERATION TO THE HEAD AFTER NICKING THE EXTENSION HEADER. THE SITE SUBSEQUENTLY BECAME RED AND SWOLLEN. THE WOUND DEVELOPED AN INFECTION, WHICH LATER EXTENDED TO OTHER COMPONENTS OF THE IMPLANTED SYSTEM, INCLUDING THE IMPLANTABLE PULSE GENERATOR (IPG) AREA. THE PATIENT WAS INITIATED ON ANTIBIOTICS. CULTURES WERE OBTAINED; HOWEVER, THE RESULTS WERE NOT PROVIDED. THE DEVICES WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

  Patient problems: Bacterial Infection; Erythema; Swelling/ Edema

  MAUDE report 23991911 ↗
• InjuryDec 22, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE LEAD EXTENSIONS OF THE DEEP BRAIN STIMULATION (DBS) WERE REPLACED. THE PATIENT STATED THAT THE IPG WOULD STAND UP IN THE POCKET WHILE SHE LAID ON HER SIDE AND THAT SHE WOULD HAVE TO LAY IT FLAT. THE PHYSICIAN INDICATED THAT HE SUSPECTED THAT THE PATIENT WAS TWIDDLING THE IPG HERSELF CAUSING SIGNIFICANT COILING OF THE LEAD EXTENSIONS WHICH CAUSED HER TO EXPERIENCE TIGHTNESS IN THE NECK. THERE WERE NO FRACTURES IDENTIFIED, AND THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY AS PER THEIR POLICY.

  Patient problems: Discomfort

  MAUDE report 23873914 ↗
• InjuryDec 22, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN UNDESIRED SENSATION OF OVERSTIMULATION RESULTING IN EXCESSIVE MOVEMENT OF THE ARMS AND LEGS. THE STIMULATION WAS TURNED OFF WITH THE REMOTE CONTROL (RC) HOWEVER, THE SENSATION REMAINED. THEREFORE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE STIMULATION WAS TURNED OFF WITH A CLINICIAN PROGRAMMER (CP) AND THE UNDESIRED SENSATIONS CEASED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY.

  Patient problems: Dyskinesia; Undesired Nerve Stimulation

  MAUDE report 23873799 ↗
• MalfunctionDec 18, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENTS DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) NECESSITATED FREQUENT CHARGING CYCLES. IT WAS NOTED DBS SYSTEM HAD BEEN REPROGRAMMED PRIOR TO THE ONSET OF THESE ISSUES, AND IMPEDANCE MEASUREMENTS WERE WITHIN RANGE. DATA ANALYSIS INDICATED VOLTAGE FLUCTUATIONS DURING AND AFTER CHARGING, BEGINNING APPROXIMATELY THREE MONTHS AGO. THE BATTERY VOLTAGE SPIKED TO FULL DURING CHARGING BUT DROPPED SIGNIFICANTLY POST-CHARGE, EXHIBITING RAPID BATTERY DEPLETION FOLLOWING A FULL CHARGE. THE ROOT CAUSE OF THIS BEHAVIOR COULD NOT BE DETERMINED WITH THE DATA ANALYSIS. A LABELING REVIEW CONFIRMED THAT NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. THE IPG WAS APPROVED FOR WARRANTY REPLACEMENT, AND THE PATIENT UNDERWENT A PROCEDURE TO REPLACE IT WITH AN IDENTICAL MODEL. POSTOPERATIVELY, THE PATIENT RECOVERED WELL AND NO LONGER EXPERIENCES CHARGING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843971 ↗
• InjuryDec 15, 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 PARTIAL EXPLANT FOR AN UNKNOWN REASON. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812784 ↗
• InjuryDec 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 DEVELOPED REDNESS AND SWELLING AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSION INCISION SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND PORTION OF THE LEAD EXTENSIONS WERE REMOVED DUE TO INFECTION. IT IS UNCLEAR WHETHER CULTURES WERE OBTAINED DURING THE PROCEDURE. DEVICE ANALYSIS WAS NOT PERFORMED, AS THE FACILITY RETAINED THE COMPONENTS PER ITS POLICY. THE PATIENT RECEIVED ANTIBIOTICS AND FULLY RECOVERED. THE REMAINING LEAD EXTENSIONS PARTS WERE COMPLETELY REMOVED AT A LATER DATE DURING A REIMPLANT OF DEVICES. REMAINING LEAD EXTENSION SEGMENTS WERE REMOVED DURING A SUBSEQUENT REIMPLANTATION. THE REIMPLANTING PHYSICIAN ATTRIBUTED THE INFECTION TO THE DEVICE BUT DID NOT PROVIDE SUPPORTING RATIONALE. DEVICE ANALYSIS OF THE REMAINING LEAD EXTENSION SEGMENTS WAS NOT PERFORMED, AS THE FACILITY RETAINED THE COMPONENTS PER ITS POLICY. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 23795288 ↗
• InjuryDec 12, 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: Discomfort; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 23791472 ↗

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-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