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	Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite good-faith efforts, additional details from the facility were not obtained.Section b3: approximated based on the date the manufacturer became aware of the event.Section d6b: date of explant unknown.Approximated late may.Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5001005, udi: (b)(4).Product family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5001028, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient developed redness and swelling at the implantable pulse generator (ipg) and lead extension incision site.The patient underwent a procedure wherein the ipg and portion of the lead extensions were removed due to infection.Device analysis was not performed, as the facility retained the components per its policy.The patient received antibiotics and fully recovered.The remaining lead extensions parts were completely removed at a later date during a reimplant of devices.Remaining lead extension segments were removed during a subsequent reimplantation.The reimplanting physician attributed the infection to the device but did not provide supporting rationale.Device analysis of the remaining lead extension segments was not performed, as the facility retained the components per its policy.
Additional Manufacturer Narrative
Sections b5 describe event or problem, b6 relevant tests, d6 explant date and e1, e2, e3 initial reporter updated.Section 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-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5001005.Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5001028.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient developed redness and swelling at the implantable pulse generator (ipg) and lead extension incision site.The patient underwent a procedure wherein the ipg and portion of the lead extensions were removed due to infection.It is unclear whether cultures were obtained during the procedure.Device analysis was not performed, as the facility retained the components per its policy.The patient received antibiotics and fully recovered.The remaining lead extensions parts were completely removed at a later date during a reimplant of devices.Remaining lead extension segments were removed during a subsequent reimplantation.The reimplanting physician attributed the infection to the device but did not provide supporting rationale.Device analysis of the remaining lead extension segments was not performed, as the facility retained the components per its policy.Additional information indicated that 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: 23795288
• Report Number: 3006630150-2025-11431
• Device Sequence Number: 10470720
• Product Code: PJS
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)261022(10)773898
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 773898
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 10/22/2024
• 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: 80 YR
• Patient Sex: Female