Vercise™ DB-1110-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 08714729820758), received between Jan 17, 2018 and Sep 25, 2026 — classified as 93 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (27 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 98 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Off-Label Use; Wireless Communication Problem; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906265 ↗
• InjurySep 23, 2026Charging Problem

  It was reported that the patient that is implanted with the Deep Brain Stimulation (DBS) system Implantable Pulse Generator (IPG) experienced difficulty charging. The patient attempted to charge their IPG with different devices but was unable to do so. The patient underwent a procedure in which the IPG was replaced.The patient did not experience any stimulation effects due to the difficulty charging as the system continued to provide adequate therapy and is doing well post operatively. The IPG will not be returned as it was retained by the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863921 ↗
• InjuryAug 6, 2026Unexpected Therapeutic Results; Charging Problem

  It was reported that a deep brain stimulation (DBS) patient was taken to the emergency department due to worsening dystonia symptoms believed to be associated with inadequate stimulation. Investigation revealed that the implantable pulse generator (IPG) had not been charged properly because the patient was not using the charging system correctly. Following assistance with the charging process, the device was evaluated and found to be functioning as intended, with adequate battery status and normal impedance measurements. The patients symptoms subsequently returned to baseline, and the patient was discharged approximately one hour later. Further information indicated that the patient had recently lost her hearing aids and was unable to hear the charger beep notifications, which contributed to the improper charging of the IPG.

  Patient problems: Movement Disorder

  MAUDE report 50159969 ↗
• InjuryJul 31, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep Brain Stimulation (DBS) patient experienced pain behind the ear. Upon examination, the connection between the non-Boston Scientific lead and the non-Boston Scientific extension was found to be exposed through the skin. Additionally, the patient experienced pain at the Implantable Pulse Generator (IPG) pocket site, which was presumed to be associated with an infection, as symptoms consistent with inflammation were observed. Based on the available information, it is believed that the infection spread to the IPG through the exposed connection between the non-Boston Scientific lead and the non-Boston Scientific extension. Despite this, the patient continued to obtain therapeutic benefit from DBS therapy, and there were no allegations regarding the performance of the Boston Scientific devices. Due to this, the patient underwent an explant procedure of the IPG, adapters, and non-Boston Scientific devices. The procedure involved making an incision approximately 5 cm above the left connection site, followed by transection of the non-Boston Scientific lead. A separate incision was then made in the right chest, where the non-Boston Scientific lead component of t

  Patient problems: Implant Pain; Insufficient Information; Unspecified Infection

  MAUDE report 50101985 ↗
• InjuryJul 17, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) WHEN, WITHIN SECONDS OF PLACING THE CHARGER OVER THE IPG, THE CHARGING COMPLETE TONE WAS EMITTED. BASED ON THIS INDICATION, THE PATIENT DISCONTINUED CHARGING; HOWEVER, STIMULATION CEASED IMMEDIATELY, RESULTING IN THE ONSET OF SYMPTOMS. CONSEQUENTLY, THE PATIENT PRESENTED TO THE CLINIC ON AN URGENT BASIS FOR EVALUATION. DURING THE ASSESSMENT, STIMULATION COULD ONLY BE MAINTAINED WHILE THE CHARGER REMAINED POSITIONED OVER THE IPG. THE CHARGER CONTINUOUSLY EMITTED AN AUDIBLE TONE INDICATING THAT CHARGING WAS IN PROGRESS. FURTHER TROUBLESHOOTING WAS PERFORMED, INCLUDING THE USE OF THE HOSPITAL'S CHARGER; HOWEVER, THE ISSUE PERSISTED. IN ADDITION, ATTEMPTS TO ESTABLISH COMMUNICATION WITH THE IPG USING BOTH THE PROGRAMMER AND THE CONTROLLER WERE UNSUCCESSFUL. BASED ON THE CLINICAL FINDINGS AND DEVICE BEHAVIOR, IT WAS SUSPECTED THAT THE IPG BATTERY HAD BEEN ADVERSELY AFFECTED BY AN EXTERNAL FACTOR. THEREFORE, THE PLANNED IPG REPLACEMENT PROCEDURE WAS EXPEDITED AND PERFORMED EARLIER THAN ORIGINALLY SCHEDULED.

  Patient problems: Shaking/Tremors

  MAUDE report 25864046 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT REMAINS AT BASELINE STATUS FOLLOWING THE PROCEDURE. THE EXPLANTED IPG WILL NOT BE RETURNED FOR ANALYSIS, AS THE FACILITY HAS ALREADY DISPOSED OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465728 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT OF THE IPG DUE TO AN UNSPECIFIED REASON. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112969 ↗
• InjuryMar 16, 2026High impedance; Charging Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT HAD TROUBLE FULLY CHARGING THEIR SUB CLAVICULAR IMPLANTABLE PULSE GENERATOR (IPG), RESULTING IN FREQUENT CHARGING ATTEMPTS. ADDITIONAL TRAINING AND CHARGING CYCLES WERE PERFORMED BUT DID NOT RESOLVE THE ISSUE. DATA LOG ANALYSIS IDENTIFIED HIGH IMPEDANCE ON ONE CONTACT, FREQUENT CHARGING CYCLES, AND CONSISTENT INTERRUPTION OF CHARGING AT 3.8V. ANALYSIS ALSO SHOWED INTERRUPTIONS AND LOW CHARGE CURRENT, SUGGESTING SUBOPTIMAL CHARGER TO IPG ALIGNMENT, A POTENTIAL CHARGER MALFUNCTION, OR ACTIVATION OF THE THERMISTOR DURING CHARGING. ENGINEERING WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THEY RECOMMENDED THAT THE PATIENT ALLOW THE IPG TO DISCHARGE BELOW 3.8V AND THEN PERFORM A TWO HOUR CHARGE CYCLE UNTIL THE DOUBLE BEEP CONFIRMATION IS REACHED. THE PATIENT WAS ADMITTED FOR FURTHER EVALUATION AND REMAINS UNDER THE CARE OF THEIR PHYSICIAN. THE IPG REMAINS IMPLANTED, AND NO STIMULATION ISSUES HAVE BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED NO SURGICAL OR MEDICAL INTERVENTION WAS PERFORMED DURING HOSPITALIZATION AND CHARGING ISSUES HAVE BEEN RESOLVED THROUGH ADDITIONAL TRAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613814 ↗
• InjuryMar 10, 2026Charging Problem

  THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO INCREASED CHARGING DURATION. ATTEMPTS AT CHARGING REEDUCATION WERE UNSUCCESSFUL. NO WEIGHT CHANGES WERE REPORTED THAT COULD HAVE CONTRIBUTED TO THE ISSUE. THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE IN WHICH THE IPG WAS EXPLANTED AND REPLACED. ELECTROCAUTERY WAS UTILIZED DURING THE PROCEDURE. THE HOSPITAL DISPOSED OF THE EXPLANTED DEVICE, AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE PATIENT IS REPORTED TO BE DOING WELL, WITH NO POSTOPERATIVE COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563734 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DESPITE GOOD FAITH EFFORTS. THE LOCATION OF THE EXPLANTED DEVICE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461303 ↗
• InjuryJan 6, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING INADEQUATE STIMULATION RESULTING IN A LACK OF TREMOR CONTROL. THERE WERE SEVERAL ATTEMPTS AT PROGRAMMING THE THERAPY TO ACHIEVE MORE OPTIMAL TREMOR CONTROL BUT WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE TWO PORT IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED WITH A 4 PORT 32 CONTACT IPG TO ACCOMMODATE ADDITIONAL LEAD IMPLANT AT A LATER DATE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS RETAINED BY THE MEDICAL FACILITY AND WAS NOT RETURNED. THE PHYSICIAN ASSESSED THAT THE LEADS THAT WERE INITIALLY IMPLANTED WERE NOT OPTIMALLY PLACED AND MAY HAVE BEEN THE CAUSE FOR THE LACK OF TREMOR CONTROL.

  Patient problems: Shaking/Tremors

  MAUDE report 23976503 ↗
• InjuryDec 24, 2025Unexpected Therapeutic Results; Charging Problem; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) RESULTING IN HOSPITALIZATION DUE TO A LOSS OF STIMULATION. THE PHYSICIAN ASSESSED THAT THE CONDITION POSSIBLY DEVELOPED DUE TO THE ONSET OF DYSKINESIA CAUSED BY THE PATIENTS INABILITY TO CHARGE THE IPG. THE PATIENT IS CURRENTLY STABLE BUT REMAINS IN THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED ANOTHER EPISODE OF SEVERE DYSKINESIA AND WAS URGENTLY ADMITTED TO THE HOSPITAL. THE PATIENTS CONDITION HAS STABILIZED AND PATIENT WAS DISCHARGED. THE PHYSICIAN ASSESSED AFTER CHECKING THE SYSTEM USING THE REMOTE CONTROL (RC) THAT THERE APPEARED TO BE NO ISSUE WITH THE IPG CHARGING OR ITS OPERATION. ALTHOUGH THE CAUSAL RELATIONSHIP IS UNKNOWN. DRAFT.

  Patient problems: Dyskinesia

  MAUDE report 23889520 ↗
• InjuryNov 13, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT STATED THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPIRED, HOWEVER, THE PATIENT CONTINUED TO RECEIVE ADEQUATE THERAPY FROM THEIR DEVICE. AND NO ADVERSE SYMPTOMS OR MALFUNCTIONS WERE IDENTIFIED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND IS DOING WELL POST OPERATIVELY. DEVICE ANALYSIS CANNOT BE COMPLETED, AS IT WILL NOT BE RETURNED DUE TO HAVING BEEN DISPOSED OF BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551143 ↗
• MalfunctionOct 24, 2025Nonstandard Device; Wireless Communication Problem; Nonstandard Device; Wireless Communication Problem

  IT WAS REPORTED THAT COMMUNICATION COULD NOT BE ESTABLISHED BETWEEN THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) AND REMOTE CONTROL (RC) AND CLINICIAN PROGRAMMER (CP). SEVERAL ATTEMPTS WERE MADE TO CONNECT TO THE IPG USING THE RC AND CP BUT WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. PREOPERATIVELY THEY WERE ABLE TO ESTABLISH A SUCCESSFUL CONNECTION TO THE IPG WITH THE CP AND RC. THE PHYSICIAN SUSPECTED THAT THE PREVIOUS COMMUNICATION ISSUES WERE POSSIBLY CAUSED BY RADIO FREQUENCY (RF) INTERFERENCE IN THE CLINIC ENVIRONMENT FROM THE COMPUTER, BADGE READER, SCANNER, ETC. DISRUPTING COMMUNICATION WITH THE IPG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379941 ↗
• InjuryOct 15, 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 PATIENT WITH A DEEP BRAIN STIMULATION (DBS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE FOR AN UNSPECIFIED REASON. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DBS IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO INADEQUATE STIMULATION, AS A CONSEQUENCE, THE PATIENT EXPERIENCED TROUBLESOME DYSKINESIA. THE IPG WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING GOOD.

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

  MAUDE report 23297358 ↗
• InjuryAug 11, 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 REPLACEMENT SURGERY DURING WHICH ALL IMPLANTED DEVICES WERE REMOVED. THE REASON FOR THE EXPLANTATION REMAINS UNKNOWN. THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE THERE WERE NO ISSUES DURING THE SURGERY, AND THE DEVICE WAS FUNCTIONING PROPERLY. THE DBS SYSTEM WAS ELECTIVELY REPLACED TO BETTER ALIGN WITH THE PROGRESSION OF THE DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779265 ↗
• InjuryJul 28, 2025Unexpected Therapeutic Results; Wireless Communication Problem; Unexpected Therapeutic Results; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING DIFFICULTY ESTABLISHING COMMUNICATION BETWEEN THE REMOTE CONTROL AND THE IMPLANTABLE PULSE GENERATOR (IPG), WHICH LED TO SYMPTOMS OF SLOWED MOVEMENT AND WEAKNESS. THROUGHOUT THE DAY, THERE WAS NO IMPROVEMENT, AND THE PATIENT WAS LATER ADMITTED TO THE EMERGENCY ROOM DUE TO A CHOKING INCIDENT. IT WAS DISCOVERED THAT THE STIMULATION HAD INADVERTENTLY BEEN TURNED OFF; THEREFORE, THE STIMULATION WAS REACTIVATED AFTER WHICH THE PATIENT IMMEDIATELY BECAME MORE RESPONSIVE. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. THE DEVICE WILL NOT RETURN FOR ANALYSIS AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT, BASED ON THE PHYSICIAN'S ASSESSMENT, THE CHOKING EPISODE IS CONSIDERED PART OF THE PATIENTS DISEASE PROGRESSION.

  Patient problems: Insufficient Information; Movement Disorder; Muscle Weakness/Atrophy

  MAUDE report 22638313 ↗
• InjuryJul 21, 2025Charging Problem; Wireless Communication Problem; Migration; Charging Problem; Wireless Communication Problem; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DIFFICULTY CHARGING AND COMMUNICATING WITH THEIR IMPLANTABLE PULSE GENERATOR (IPG). RADIOGRAPHIC IMAGING REVEALED THAT THE IPG HAD ROTATED FROM ITS ORIGINAL POSITION, WAS SITUATED UNUSUALLY LOW IN THE CHEST, AND EXHIBITED EXCESSIVE MOBILITY. THE PHYSICIAN DETERMINED THAT IPG MIGRATION WAS THE LIKELY CAUSE OF THE PATIENTS CHARGING AND COMMUNICATION ISSUES. CONSEQUENTLY, THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE. THE IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556283 ↗
• InjuryJun 27, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO DIFFICULTY WITH DEVICE RECHARGING. NO ADDITIONAL ADVERSE EFFECTS WERE OBSERVED OR REPORTED. PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS DISCHARGED THE SAME DAY. THE DEVICE WAS DISCARDED IN THE OPERATING ROOM AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349729 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Wireless Communication Problem; Adverse Event Without Identified Device or Use Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED IMPLANTABLE PULSE GENERATOR (IPG) TO CLINICIAN PROGRAMMER (CP) COMMUNICATION DIFFICULTY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638044 ↗
• InjuryOct 2, 2024Unexpected Therapeutic Results; Wireless Communication Problem; Unexpected Therapeutic Results; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A LACK OF TREMOR AND SPEECH CONTROL. X-RAY IMAGING CONFIRMED THE LEADS AND LEAD EXTENSIONS WERE APPROPRIATELY PLACED. TROUBLESHOOTING AND REPROGRAMMING EFFORTS WERE UNSUCCESSFUL, AND EVENTUALLY THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD NO LONGER COMMUNICATION WITH THE CLINICIAN PROGRAMMER (CP). THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED AND DID WELL POSTOPERATIVELY.

  Patient problems: Shaking/Tremors; Speech Disorder

  MAUDE report 20355819 ↗
• InjurySep 19, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTIES COMMUNICATING BETWEEN HIS DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG). ATTEMPTS TO ESTABLISH COMMUNICATION WITH THE IPG AND SEVERAL REMOTE CONTROLS AND CLINICIAN PROGRAMMERS WERE MADE, HOWEVER WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A PROCEDURE WHERE THE IPG WAS REPLACED WITH ANOTHER OF A DIFFERENT MODEL. THE PATIENT DID WELL POST-OPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263860 ↗
• InjuryAug 28, 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 EXPERIENCED PAIN, DISCOMFORT AND A MILD BURNING SENSATION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WHILE CHARGING AFTER UNDERGOING A ROUTINE MAMMOGRAM APPOINTMENT. THE PATIENT REPORTED THE MAMMOGRAM TECHNICIAN HANDLED HER BREAST AREA ROUGHLY WHERE THE IPG WAS IMPLANTED AND IS THE CAUSE OF THE PAIN, DISCOMFORT AND BURNING SENSATIONS WHILE CHARGING. INSPECTION OF THE DEVICE REVEALED THE CHARGER WAS FUNCTIONING WELL AND IMPEDANCE MEASUREMENTS WERE NORMAL, HOWEVER, IT WAS DECIDED TO REPLACE THE IPG WITH A MAGNETIC RESONANCE IMAGING (MRI) ELIGIBLE DEVICE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL AND WAS NOT RETURNED TO BSC.

  Patient problems: Burning Sensation; Discomfort; Implant Pain

  MAUDE report 20089435 ↗
• InjuryAug 23, 2024Unexpected Therapeutic Results; Charging Problem; Migration; Unexpected Therapeutic Results; Charging Problem; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) WHEREIN HAVING TO CHARGE FOR MULTIPLE HOURS TO NO EFFECT, CAUSING A LOSS IN STIMULATION. THE DEVICE HAD MIGRATED BENEATH THE TISSUE AND FLIPPED BACKWARDS AND BECAME VERY DIFFICULT TO CHARGE EFFECTIVELY, AND THE DEVICE HAD GONE INTO HIBERNATION MODE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICE WAS RETAINED BY THE MEDICAL FACILITY AND WAS NOT RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 20057800 ↗
• InjuryJun 28, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS HAVING DIFFICULTY CHARGING THEIR IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS EDUCATED ON THE RECHARGING PROCESS, BUT THE ISSUE PERSISTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS EXPLANTED AND REPLACED AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634393 ↗

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