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

Model Number	DB-1200-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a history of essential tremor treated with deep brain stimulation (dbs) therapy and had previously experienced a scalp infection requiring wound washout and outpatient antibiotic treatment.The patient subsequently presented with wound dehiscence.As part of the intervention, the patient's dbs system was explanted due to the wound dehiscence.Postoperative patient status was not available.Additional information regarding the reported infection and the patient's postoperative condition could not be obtained, as the physician and facility declined to disclose this information due to patient privacy requirements.The explanted devices will not be returned for analysis, as the hardware was not made available for return.
Additional Manufacturer Narrative
Block b3: approximated based on the procedure date.Block d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: 55cm 8 contact extension.Unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: 55cm 8 contact extension.Unique identifier (udi) #: (b)(4).

• Brand Name: Vercise Gevia?
• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50288783
• Report Number: 3006630150-2026-05976
• Device Sequence Number: 9732028
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)211126(10)741167
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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 Expiration Date: 11/26/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 741167
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 11/27/2019
• 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: 62 YR
• Patient Sex: Male