Vercise Gevia™ DB-1200-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 08714729984443), received between May 6, 2019 and Sep 30, 2026 — classified as 5 deaths, 160 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (33 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 25 most recent of 170 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Off-Label Use; Migration

  It was reported that the patient that is implanted with the off-label use of the Implantable Pulse Generator (IPG) of the Deep Brain Stimulation (DBS) system, underwent an unrelated surgery procedure causing the IPG to migrate which caused pain and discomfort while sleeping, however, it was noted that imaging was not performed to confirm migration. The patient underwent a revision procedure in which the IPG was upgraded to a new device and is doing well post operatively. The device will not be returned for analysis as it was disposed of per hospital policy.

  Patient problems: Implant Pain

  MAUDE report 50942449 ↗
• InjurySep 21, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  It was reported that the Deep brain stimulation (DBS) patient had experienced inadequate Parkinson's disease symptoms control for more than one year, particularly with respect to dyskinesia. It was also reported that the patient experiences electrical shock like sensations when stimulation is active, with the sensations radiating to the arms and legs. As a result, the patient has been unable to use the therapy consistently and has only been able to tolerate therapy during certain periods, such as overnight while sleeping. Additionally, it was reported that the patient sustained a fall approximately two years ago that resulted in a head injury. The patient was evaluated by a neurologist, and reprogramming was attempted as a troubleshooting measure; although the intervention was successful initially, after a short period of time, it was no longer effective, as dyskinesia returned shortly after the adjustment. At the time of this report, the implantable pulse generator (IPG) remains implanted.

  Patient problems: Dyskinesia; Fall; Inappropriate Device Stimulation of Tissue

  MAUDE report 50841053 ↗
• DeathAug 19, 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.Additional information was received indicating that the DBS patient was ill, and it was noted that the patient had diabetes and was overweight. The cause of death is not believed to be device related; however, it remains unconfirmed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50333773 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had a history of essential tremor treated with Deep Brain Stimulation (DBS) therapy and had previously experienced a scalp infection requiring wound washout and outpatient antibiotic treatment. The patient subsequently presented with wound dehiscence. As part of the intervention, the patient's DBS system was explanted due to the wound dehiscence. Postoperative patient status was not available. Additional information regarding the reported infection and the patient's postoperative condition could not be obtained, as the physician and facility declined to disclose this information due to patient privacy requirements. The explanted devices will not be returned for analysis, as the hardware was not made available for return.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 50288783 ↗
• InjuryAug 5, 2026Charging Problem

  It was reported that the patient experienced difficulty charging the Deep Brain Stimulation (DBS) implantable pulse generator (IPG). The patient stated that, after charging for approximately one hour, the battery displayed one-third charge. The patient also reported experiencing a shock-like sensation during charging. No device malfunction was confirmed, and evaluation of the charger indicated that it was functioning as expected. As part of the intervention, troubleshooting was performed and the patient was educated regarding the thermistor function and appropriate charging practices, including charging in two-hour intervals and ensuring adequate charger ventilation. The patient was also advised to consult with the treating physician regarding the reported shock-like sensation. The patient subsequently consulted with the treating provider and reported no recurrence of the sensation. At the time of the latest follow-up, the patient reported no additional charging-related issues. The patient indicated a desire for faster charging but understood the limitations of the recharge process and planned to charge more frequently to reduce charging duration. The patient was advised to contact

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50146038 ↗
• DeathJul 28, 2026

  It was reported that the deep brain stimulation (DBS) patient passed away for an unknown reason. The attending physician did not have information regarding the cause of death.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057298 ↗
• InjuryMay 19, 2026Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY CHARGING, AS WELL AS FORGETTING TO CHARGE, THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM CAUSING A LOSS OF THERAPY AND SYMPTOMS OF RIGIDITY. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE RECHARGEABLE IPG WAS REPLACED WITH A PRIMARY CELL DEVICE AND IS DOING WEL LPOST OPERATIVELY. THE DEVICE WAS NOT RETURNED AS IT WAS RETAINED BY THE FACILITY.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 25225535 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A SUDDEN LOSS OF CONSCIOUSNESS RESULTING IN A FALL. ADDITIONALLY, THE PATIENT EXPERIENCED RIGIDITY AND SHAKING. THEREFORE, THE PATIENT WAS HOSPITALIZED OVERNIGHT WHEREIN THE RIGIDITY CONTINUED HOWEVER, BY THE NEXT DAY SHE HAD FULLY RECOVERED. THE PHYSICIAN WAS UNSURE IF A POSSIBLE SEIZURE HAD OCCURRED AS NO REASON FOR THE EVENT WAS CONFIRMED. THE PATIENTS STIMULATION HAD BEEN TURNED ON DURING THIS EVENT HOWEVER, IT WAS UNKNOWN WHETHER THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO FURTHER COMPLICATIONS.

  Patient problems: Convulsion/Seizure; Fall; Loss of consciousness; Syncope/Fainting

  MAUDE report 25038131 ↗
• DeathApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) HAS PASSED AWAY. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE CAUSE OF DEATH WAS NOT REPORTED. THE PHYSICIAN FOR THE PATIENT PROVIDED INFORMATION THAT THE PATIENT SUFFERED FROM DEMENTIA AND THAT WAS BELIEVED TO HAVE CONTRIBUTED TO THEIR DEATH. THEY INDICATED THE STIMULATOR WAS NOT THOUGHT TO HAVE CAUSED OR CONTRIBUTED TO THE DEATH. THE STIMULATOR REMAINED IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019493 ↗
• InjuryFeb 23, 2026Unexpected Therapeutic Results; Charging Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED COMMUNICATION DIFFICULTIES WITH THE IMPLANTABLE PULSE GENERATOR (IPG) AND COULD NOT TURN THERAPY BACK ON AFTER A MEDICAL PROCEDURE AS A RESULT, THE PATIENT WAS IN PAIN AND DISCOMFORT THEREFORE WAS ADMITTED. IT WAS NOTED THAT DBS WAS FUNCTIONING PROPERLY AND THERAPY WAS MANUALLY TURNED OFF IN ORDER TO COMPLETE A CARDIOVERSION PROCEDURE. ATTEMPTS TO RECHARGE THE IPG AND REESTABLISH COMMUNICATION USING A FUNCTIONAL CLINICIAN PROGRAMMER (CP) AND REMOTE-CONTROL (RC) WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS REPLACED WITH A DIFFERENT MODEL BEFORE COMPLETING THE PROCEDURE. ANALYSIS OF THE IPG WAS NOT PERFORMED AS IT WAS DISCARDED BY THE FACILITY. THE PATIENT WAS SUCCESSFULLY PROGRAMMED RESULTING IN RETURN OF THEIR THERAPY. PATIENT DID WELL POST-OPERATIVELY. IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED PAIN AND DISCOMFORT FOLLOWING A NON-DBS MEDICAL PROCEDURE. THE PATIENT COULD NOT TURN THERAPY BACK ON AND EXPERIENCED COMMUNICATION DIFFICULTIES WITH THE IMPLANTABLE PULSE GENERATOR (IPG) RESULTING WITH PROLONGED HOSPITALIZATION. IT WAS NOTED THAT DBS WAS FUNC

  Patient problems: Discomfort; Pain

  MAUDE report 24415312 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT, THAT IS IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM FOR PARKINSON'S DISEASE, LOST CONSCIOUSNESS, WAS TAKEN TO THE HOSPITAL, AND WAS ADMITTED. THE PATIENT WAS UNDERGOING ELECTROENCEPHALOGRAM (EEG) TESTING, AND TURNED OFF THE THERAPY FROM THE DBS SYSTEM, STROBE LIGHTS FLASHED AT THE END OF THE TEST CAUSING HER PREEXISTING SYMPTOMS OF TREMORS TO RETURN EXTREMELY STRONG, THE TEST WAS STOPPED AND THE PATIENT LOST CONSCIOUSNESS AGAIN. THE PATIENT HAS ALSO EXPERIENCED INCIDENTS OF A DROP IN THEIR BLOOD PRESSURE AND LOSS OF CONSCIOUSNESS. MULTIPLE TESTS HAVE BEEN PERFORMED AND THE RESULTS HAVE BEEN NORMAL. IT HAS NOT BEEN CONFIRMED IF THE PATIENT SYMPTOMS ARE DUE TO THE DEVICE AND OR THERAPY. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION, IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Hypersensitivity/Allergic reaction; Loss of consciousness; Low Blood Pressure/ Hypotension; Shaking/Tremors; Visual Disturbances

  MAUDE report 24275234 ↗
• InjuryDec 9, 2025Unexpected Therapeutic Results; Use of Device Problem; Low impedance; Delayed Charge Time; Charging Problem; Unexpected Therapeutic Results; Use of Device Problem; Low impedance; Delayed Charge Time; Charging Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT OBSERVED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY INDICATOR DISPLAYED A LOW STATUS ON THE REMOTE CONTROL. THE PATIENT REPORTED THAT THE DEVICE REQUIRED DAILY CHARGING OVER EXTENDED INTERVALS IN ORDER TO MAINTAIN ADEQUATE BATTERY FUNCTION. SUBSEQUENT IMPEDANCE TESTING DEMONSTRATED LOW IMPEDANCE VALUES, AND THE PATIENT LATER EXPERIENCED A LOSS OF STIMULATION DUE TO COMPLETE BATTERY DEPLETION, WHICH RESULTED IN THE RECURRENCE OF TREMOR. THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Shaking/Tremors

  MAUDE report 23754018 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  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 23717480 ↗
• InjuryDec 2, 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 FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AND NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699728 ↗
• InjuryNov 24, 2025Unexpected Therapeutic Results; Charging Problem; Migration; Unexpected Therapeutic Results; Charging Problem; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED MIGRATION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THIS RESULTED IN THE INABILITY TO CHARGE THE DEVICE AND A LOSS OF STIMULATION CAUSING A RETURN OF TREMOR SYMPTOMS. 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: Shaking/Tremors

  MAUDE report 23639445 ↗
• InjuryNov 24, 2025Unexpected Therapeutic Results; Wireless Communication Problem; Unexpected Therapeutic Results; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A LOSS OF STIMULATION AND THE REMOTE CONTROL WOULD NOT COMMUNICATE WITH THE IMPLANTABLE PULSE GENERATOR (IPG) AFTER THE PATIENT HAD UNDERWENT A CARDIOVERSION PROCEDURE. AFTER ATTEMPTING TO CHARGE THE IPG SEVERAL TIMES, THE REMOTE WOULD STILL NOT COMMUNICATE. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE IPG WAS REPLACED. THE PATIENT HAS RECOVERED POSTOPERATIVELY. THE EXPLANTED IPG WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 23635703 ↗
• InjuryNov 8, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO CHARGING DIFFICULTIES. THE PATIENT IS DOING GREAT POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23506511 ↗
• InjuryOct 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING HIGH IMPEDANCES ON THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE IPG WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISPOSED OF BY THE MEDICAL FACILITY AND WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383923 ↗
• InjurySep 24, 2025High impedance; Off-Label Use; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; High impedance; Off-Label Use; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE WHERE IN THE IMPLANTABLE PULSE GENERATOR (IPG), AND LEAD EXTENSIONS WERE REVISED FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION INDICATED THE DEEP BRAIN STIMULATION (DBS) PEDIATRIC PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO HIGH IMPEDANCES OBSERVED ON BOTH LEADS. ACCORDING TO THE TREATING PHYSICIAN, THESE HIGH IMPEDANCES WERE LIKELY CAUSED BY EXCESSIVE HEAD MOVEMENTS. THE PATIENT HAD PREVIOUSLY EXPERIENCED ELEVATED IMPEDANCE LEVELS, WHICH WERE MANAGED THROUGH DEVICE REPROGRAMMING. HOWEVER, THE ISSUE PROGRESSIVELY WORSENED, ULTIMATELY RESULTING IN INADEQUATE STIMULATION. POST OPERATIVELY THE PATIENT IS DOING GREAT, WITH THERAPY RESTORE AND IMPROVED. THE EXPLANTED DEVICE WILL BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: Movement Disorder; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23139996 ↗
• InjuryAug 12, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Intermittent Energy Output; High impedance; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Intermittent Energy Output

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION, INTERMITTENT STIMULATION AND OVERSTIMULATION RANDOMLY WHEN THE DEVICE WAS TURNED ON. HIGH IMPEDANCE READINGS WERE DISCOVERED ON THE NON-BOSTON SCIENTIFIC LEFT LEAD HOWEVER IT COULD NOT BE DETERMINED IF THE HIGH IMPEDANCE CAME FROM THE NON-BOSTON SCIENTIFIC LEAD AND LEAD EXTENSION OR THE BOSTON SCIENTIFIC IPG AND ADAPTERS. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE BOSTON SCIENTIFIC IPG AND ADAPTERS WERE EXPLANTED AND REPLACED WITH A NON-BOSTON SCIENTIFIC IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Shaking/Tremors; Undesired Nerve Stimulation

  MAUDE report 22790118 ↗
• InjuryAug 1, 2025High impedance; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; High impedance; Unexpected Therapeutic Results; 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 DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Paresthesia; Shaking/Tremors

  MAUDE report 22688670 ↗
• InjuryJul 22, 2025Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564278 ↗
• InjuryJul 18, 2025Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Undesired Nerve Stimulation

  MAUDE report 22543513 ↗
• InjuryJul 14, 2025Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERGOING DEEP BRAIN STIMULATION (DBS) THERAPY PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF A PRESSURE HEADACHE AND A PERCEIVED ODOR RESEMBLING BURNING WIRES, WHICH THE PATIENT ASSOCIATED WITH INADEQUATE STIMULATION. THE PATIENT REPORTED PERSISTENT HEAD PAIN AND DISCOMFORT REGARDLESS OF WHETHER THE STIMULATION WAS ACTIVE OR INACTIVE. UPON EVALUATION, A NEUROLOGIST CONFIRMED THAT THE DBS DEVICE WAS FUNCTIONING AS INTENDED AND CONCLUDED THAT THE SYMPTOMS WERE UNLIKELY TO BE RELATED TO THE DEVICE. NEVERTHELESS, THE PATIENT'S DEVICE WAS SUBSEQUENTLY REPROGRAMMED. ADDITIONAL DIAGNOSTIC TESTS WERE ORDERED TO FURTHER INVESTIGATE THE REPORTED SYMPTOMS, THOUGH THEY HAVE NOT YET BEEN PERFORMED. THE EVENT REMAINS ONGOING.

  Patient problems: Discomfort; Headache; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22500455 ↗
• InjuryMay 23, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT DURING THE SCHEDULED DEEP BRAIN STIMULATION (DBS) PROCEDURE, THE PHYSICIAN ENCOUNTERED A FAILURE IN ESTABLISHING COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE FUNCTIONING REMOTE CONTROL DURING DEVICE FUNCTIONAL TESTING. MULTIPLE ATTEMPTS WERE MADE TO REESTABLISH COMMUNICATION, BUT ALL EFFORTS WERE UNSUCCESSFUL. THE PHYSICIAN ELECTED TO REPLACE THE NON-COMMUNICATING IPG WITH AN ALTERNATIVE MODEL AND AS A RESULT THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE PATIENT DID WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080679 ↗

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