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	Wound Dehiscence (1154); Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2203450.Model: db-2203-45.Serial: (b)(6).Batch: 5003102.Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2203450.Model: db-2203-45.Serial: (b)(6).Batch: 5003345.Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5001802.Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5001865.Udi: (b)(4).Product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600-c.Serial: n/a.Batch: 35765308.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion leading to dehiscence at the implantable pulse generator (ipg) implant site.The physician believed the area was infected, though the infection was not considered related to the device or the procedure.It is unknown whether cultures were obtained.The patient subsequently underwent complete explantation of the dbs system before completing the procedure.Analysis of the devices was not performed as they were retained by the facility.The patient did well post-operatively.
Additional Manufacturer Narrative
With all the available information (in the absence of product return), boston scientific concludes that the reported event of dehiscence, erosion and infection is a known inherent risk as documented in the instructions for use (ifu).A review of the manufacturing documentation for all the dbs 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 instructions for use (ifu) product label.Additionally, labeling states that dehiscence, erosion and infection is a known inherent risk as documented in the ifu of implanting a pulse generator as part of a system to deliver deep brain stimulation (dbs).The dbs devices were all retained by the facility.As such, physical analysis has not been conducted in our laboratory.However, the labeling review was conducted.With the reported observations and the labeling review, it has been determined that dehiscence, erosion and infection is a known inherent risk with use of the devices as documented in the ifu.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2203450.Model: db-2203-45.Serial: (b)(6).Batch: 5003102.Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2203450.Model: db-2203-45.Serial: (b)(6).Batch: 5003345.Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5001802.Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5001865.Udi: (b)(4).Product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600-c.Serial: n/a.Batch: 35765308.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion leading to dehiscence at the implantable pulse generator (ipg) implant site.The physician believed the area was infected, though the infection was not considered related to the device or the procedure.It is unknown whether cultures were obtained.The patient subsequently underwent complete explantation of the dbs system before completing the procedure.Analysis of the devices was not performed as they were retained by the facility.The patient did well post-operatively.

• 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: 24282973
• Report Number: 3006630150-2026-00759
• Device Sequence Number: 20905368
• Product Code: NHL
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)270213(10)780253
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2026
• 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): 03/30/2026

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: 780253
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 02/13/2025
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male