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	08/01/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient passed away from natural causes.The cause of death is not believed to be device related; however, it remains unconfirmed.The patient had parkinson's disease, which was considered a comorbidity that could have contributed to the patient's death.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.D2b: additional pro code selection that applies to the indication of this device - .Additional product(s) in device system: model number/catalog number: db-3128-55b, serial number: (b)(6), batch/lot number: 5000943, model/catalog description: 55cm 2x8 lead extension kit, unique identifier (udi)#: (b)(4), model number/catalog number: db-2202-45, serial number: (b)(6), batch/lot number: 7110621, 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: 7109877, model/catalog description: dbs directional lead sterile kit 45cm, unique identifier (udi)#: (b)(4), model number/catalog number: db-4600-c, serial number: na, batch/lot number: 31573517, model/catalog description: suretek burr hole cover kit, unique identifier (udi)#: (b)(4), model number/catalog number: db-4600-c, serial number: na, batch/lot number: 31979789, model/catalog description: suretek burr hole cover kit, 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: 50820364
• Report Number: 3006630150-2026-06887
• Device Sequence Number: 18694771
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)250912(10)584963
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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 Expiration Date: 09/12/2025
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 584963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 09/13/2023
• 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 Age: 77 YR
• Patient Sex: Male