MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE?; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number	DB-1110-C
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Charging Problem (2892)
Health Effect - Clinical Code	Dyskinesia (2363)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-chargers, upn: m365db6412euc0, model: db-6412euc, serial: (b)(6), batch: 18713686, udi: (b)(4).
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Device technical analysis: the device was not returned as it remains implanted in the patient.As such, physical analysis has not been conducted in our laboratory.Device history record review: a review of the manufacturing records associated with this device indicated that it was successfully processed according to requirements.The dhr did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.Labeling review: a labelling review was performed based on the dfu and it did not reveal any anomalies as it states, weakness, muscle spasms, shaking, restlessness, problems with movement and a loss of adequate stimulation are known risk with the use of deep brain stimulation (dbs).Investigation conclusion: the device was not returned as it remains implanted in the patient.As such, physical analysis has not been conducted in our laboratory.However, a labeling review was conducted.This review determined that the reported event of loss of stimulation is a known risk associated with the use of deep brain stimulation (dbs) as documented in the instructions for use (ifu).
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Update to field h11: additional mfr narrative - added database analysis.Database analysis: analysis of the ipg database was performed.The analysis confirms the observed and reported hibernation event in early december 2025 and changes to therapy observed in early january 2026.After the hibernation event, the ipg was charged, and the patient had since been able to fully charge the ipg consistently.In 2026, stimulation remained on with the exception of two intervals, from (b)(6) 2026 to (b)(6) 2026 (approximately 1.5 days) and on (b)(6) 2026 for roughly 10 hours.During this period in 2026, programs 1 and 3 were utilized.From (b)(6) 2025 through (b)(6)2026 the patient used program 1.On 02 jan 2026 stimulation appears to have been manually turned off and on (b)(6) 2026 stimulation was turned back on and switched to program 3.On (b)(6) 2026, the patient program was subsequently changed from program 3 back to program 1, which remained active whenever stimulation was on.These therapy adjustments in 2026 appear to have been made manually using either the clinician programmer (cp) or remote control (rc).Device technical analysis: the device was not returned as it remains implanted in the patient.As such, physical analysis has not been conducted in our laboratory.Device history record review: a review of the manufacturing records associated with this device indicated that it was successfully processed according to requirements.The dhr did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.Labeling review: a labelling review was performed based on the dfu and it did not reveal any anomalies as it states, weakness, muscle spasms, shaking, restlessness, problems with movement and a loss of adequate stimulation are known risk with the use of deep brain stimulation (dbs).Investigation conclusion: the device was not returned as it remains implanted in the patient.As such, physical analysis has not been conducted in our laboratory.However, analysis of the ipg database was performed.The analysis confirmed that after the hibernation event, the ipg was able to be fully charged, and the patient had since been able to charge the ipg consistently.Additionally, a labeling review was conducted.This review determined that the reported event of loss of stimulation is a known risk associated with the use of deep brain stimulation (dbs) as documented in the instructions for use (ifu).

• Brand Name: VERCISE?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23889520
• Report Number: 3006630150-2025-11656
• Device Sequence Number: 9464545
• Product Code: NHL
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/15/2017
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 18361920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 03/05/2026; 04/18/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/30/2026; 03/31/2026; 05/15/2026
• Date Device Manufactured: 09/15/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female