VerciseRecalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 127
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls
- 0
We found 5 models of Vercise by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 127 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2018 and Sep 25, 2026 — classified as 119 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (28 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Vercise problems
Device problems
- Adverse Event Without Identified Device or Use Problem48
- Charging Problem28
- Unexpected Therapeutic Results25
- High impedance24
- Wireless Communication Problem12
- Migration8
- Delayed Charge Time7
- Device Displays Incorrect Message3
Patient problems
- No Code Available37
- No Clinical Signs, Symptoms or Conditions29
- Inadequate Pain Relief11
- Movement Disorder11
- Shaking/Tremors9
- Unspecified Infection9
- Discomfort7
- Neurological Deficit/Dysfunction6
Vercise models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vercise™ DB-1110-CSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS98 reports
- Vercise™ DB-9218-15Stimulator, electrical, implanted, for essential tremor25 reports
- Vercise™ DB-9218-55STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS2 reports
- Vercise™ DB-9208-15Stimulator, electrical, implanted, for parkinsonian symptoms1 report
- Vercise™ DB-64125-USSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS1 report
Recent Vercise adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryFeb 18, 2026High impedance; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION WHICH RESULTED IN A RETURN OF THEIR PARKINSON'S DISEASE SYMPTOMS BRADYKINESIA AND RIGIDITY. IT WAS DISCOVERED THAT THERE WERE HIGH IMPEDANCE READINGS ON THE NON-BOSTON SCIENTIFIC RIGHT-SIDED LEAD EXTENSION. THE SUBPECTORAL IMPLANTABLE PULSE GENERATOR (IPG) WAS PALPATED BY THE PHYSICIAN TO TROUBLESHOOT THE ISSUE HOWEVER, THIS DID NOT RESOLVE THE IMPEDANCE ISSUE. X-RAY IMAGING WAS TAKEN WHICH DID NOT REVEAL ANY APPARENT ANOMALIES. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH ONE OF THE BSC ADAPTERS WAS EXPLANTED AND REPLACED WHICH DID NOT RESOLVE THE IMPEDANCE ISSUE. THE PHYSICIAN THEN DECIDED TO REPLACE THE NON-BSC LEAD EXTENSION AFTER WHICH THE IMPEDANCE ISSUE WAS THEN RESOLVED AND THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. THE EXPLANTED ADAPTER WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.
Patient problems: Insufficient Information
MAUDE report 24384403 ↗InjuryJan 15, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A JOLTING SENSATION AFTER HELPING HER SPOUSE UP FROM A FALL. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH AN M8 ADAPTER WAS EXPLANTED AND REPLACED. THE PATIENTS DBS DEVICE WAS REPROGRAMMED POSTOPERATIVELY AND THE CURRENT SETTINGS WERE SATISFACTORY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.
Patient problems: Undesired Nerve Stimulation
MAUDE report 24090272 ↗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 ↗
Other Boston Scientific Neuromodulation Corporation products
- Precision Spectra3 models · 11,348 reports
- Spectra WaveWriter4 models · 7,251 reports
- Precision17 models · 6,725 reports
- WaveWriter Alpha3 models · 4,356 reports · 1 recall
- Precision Montage MRI2 models · 4,332 reports
- Linear ST5 models · 4,068 reports
- Infinion CX2 models · 2,139 reports · 1 recall
- Superion5 models · 1,488 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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