MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise Genus?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-1232
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Speech Disorder (4415)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to boston scientific for analysis.The instructions for use (ifu) identifies seizures and neurological effects as potential risks associated with the use of the deep brain stimulation (dbs) device, including seizures and speech or language difficulties.A record review determined that the reported seizures and subsequent nonverbal condition occurred during and after the implant procedure prior to initiation of stimulation and are consistent with events related to the surgical intervention rather than device performance.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of: adverse event related to procedure.D2b: additional pro code selection that applies to the indication of this device - .
Event or Problem Description
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.

• Brand Name: Vercise Genus?
• Common Device Name: stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25124230
• Report Number: 3006630150-2026-02983
• Device Sequence Number: 18351292
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)271112(10)808198
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 808198
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 06/02/2026; 07/10/2026; 09/07/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/29/2026; 07/31/2026; 09/28/2026
• Date Device Manufactured: 11/12/2025
• 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; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female