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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
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.
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 information was received stating that according to the treating neurologist, the cause of death was reported as a heart attack.No patient symptoms, device malfunctions, or adverse events preceding the death were reported.Based on the physician's assessment, the death was not considered related to the dbs device or therapy.No information was provided regarding any recent procedures that may have caused or contributed to the death.No autopsy results were available.Information regarding comorbidities that may have contributed to the patient's death was not provided.No further information has been obtained.
Additional Manufacturer Narrative
Block b2: approximated based on the date the manufacturer became aware of the event.Block b3: approximated based on 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-4600-c, serial number: na, batch/lot number: 36188564, model/catalog description: suretek burr hole cover kit, unique identifier (udi) #: (b)(4).Model number/catalog number: db-2203-45, serial number: (b)(6), batch/lot number: 5002379, model/catalog description: argyle lead 45cm sterile kit, unique identifier (udi) #: (b)(4).Model number/catalog number: db-2203-45 serial number: (b)(6), batch/lot number: 5002245, model/catalog description: argyle lead 45cm sterile kit, unique identifier (udi) #: (b)(4).Model number/catalog number: db-3216-55, serial number: (b)(6), batch/lot number: 5001327, model/catalog description: argyle extension 55cm sterile kit, unique identifier (udi) #: (b)(4).Model number/catalog number: db-3216-55, serial number: (b)(6), batch/lot number: 5001630, model/catalog description: argyle extension 55cm sterile kit, unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Correction to the initial mdr in block(s) b2.Block b2: approximated based on the date the manufacturer became aware of the event.Block b3: approximated based on 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-4600-c serial number: na batch/lot number: 36188564 model/catalog description: suretek burr hole cover kit unique identifier (udi) #: (b)(4).Model number/catalog number: db-2203-45 serial number: (b)(6) batch/lot number: 5002379 model/catalog description: argyle lead 45cm sterile kit unique identifier (udi) #: (b)(4).Model number/catalog number: db-2203-45 serial number: (b)(6).Batch/lot number: 5002245 model/catalog description: argyle lead 45cm sterile kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-3216-55 serial number: (b)(6) batch/lot number: 5001327 model/catalog description: argyle extension 55cm sterile kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-3216-55 serial number: (b)(6).Batch/lot number: 5001630 model/catalog description: argyle extension 55cm sterile 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 ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50145823
• Report Number: 3006630150-2026-05599
• Device Sequence Number: 10656639
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)270422(10)785637
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2026

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: 785637
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 04/22/2025
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female