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

Model Number	DB-1232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good-faith efforts were made to obtain additional information regarding the event; however, no further details were available.Block d2b additional pro codes, nhl, pjs.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5002143, udi: (b)(4).Product family: dbs-linear leads, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5003730, udi: (b)(4).Product family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5002419, udi: (b)(4).Product family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5000915, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient reported discomfort, redness, swelling, and purulent discharge at the implantable pulse generator (ipg) and lead incision sites.The patient subsequently underwent removal of the dbs system.According to the physician, the infection was not attributed to the device or the procedure, though no alternative cause was provided.Device analysis was not performed as the components were retained by the medical facility.The patient was treated with antibiotics and made a full recovery.
Additional Manufacturer Narrative
Based on the available information (in the absence of all the products being returned) boston scientific has determined that infection, discomfort, redness, swelling, and purulent discharge at the implantable pulse generator (ipg) and lead incision sites are a known inherent risk with the use of deep brain stimulation (dbs) as documented in the instructions for use (ifu).A review of all the manufacturing documentations for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the devices were used per the ifu product label.Additionally, implant site complications such as infection, discomfort, redness, swelling, and purulent discharge are noted within the ifu as a potential risk associated with the use of the device.The ipg, leads and lead extensions were not returned as they were retained by the facility; as such, physical analysis has not been conducted in our laboratory.The ipg, leads and lead extensions were not returned, as such, physical analysis has not been conducted in our laboratory.However, the labeling review was conducted.This review determined that infection, discomfort, redness, swelling, and purulent discharge is a known inherent risk of implanting a pulse generator as part of a system to deliver deep brain stimulation (dbs).Additional suspect medical device components involved in the event/device evaluation: product family: dbs-linear leads.Upn: m365db2203450.Model: db-2203-45.Serial: (b)(6).Batch: 5002143.Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2203450.Model: db-2203-45.Serial: (b)(6).Batch: 5003730.Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5002419.Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5000915.Udi: (b)(4).Block d2b additional pro codes, nhl, pjs.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient reported discomfort, redness, swelling, and purulent discharge at the implantable pulse generator (ipg) and lead incision sites.The patient subsequently underwent removal of the dbs system.According to the physician, the infection was not attributed to the device or the procedure, though no alternative cause was provided.Device analysis was not performed as the components were retained by the medical facility.The patient was treated with antibiotics and made a full recovery.Good-faith efforts were made to obtain additional information regarding the event; however, no further details were available.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24434612
• Report Number: 3006630150-2026-01082
• Device Sequence Number: 18716644
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)261018(10)767639
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 767639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 10/18/2024
• 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: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White