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

Model Number	DB-1216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient implanted with a deep brain stimulation (dbs) system passed away.The cause of death is unknown.No further information has been obtained.
Additional Manufacturer Narrative
Block b2-b3: approximated two weeks before the date the manufacturer became aware of the event.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 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 E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50831583
• Report Number: 3006630150-2026-06923
• Device Sequence Number: 21398177
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)270818(10)802079
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 09/18/2026

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-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 802079
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 08/17/2025
• 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: Death
• Patient Sex: Female