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	10/01/2025
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.Based on the physician's assessment, the death was not considered related to the dbs device or therapy.No recent procedures were reported that may have caused or contributed to the patient's death.The provider was unable to obtain additional information regarding the death; however, the patient's husband reported that the patient passed away in (b)(6) 2025.No autopsy results were available.The provider reported that the patient was severely overweight and experienced chronic shortness of breath; however, it is unknown whether these conditions contributed to the patient's death.No further information has been obtained.
Additional Manufacturer Narrative
Block b2: approximated based on the month (october 2025) provided by sales employee.Block b3: approximated based on the month (october 2025) provided by sales employee.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: 7104216 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: 7115696 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: 7116785 model/catalog description: 55cm 8 contact extension unique identifier (udi) #: (b)(4).Model number/catalog number: db-4600-c serial number: na batch/lot number: 31313102 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: 50622700
• Report Number: 3006630150-2026-06519
• Device Sequence Number: 18815793
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)250528(10)574213
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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 Expiration Date: 05/27/2025
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 574213
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 05/28/2023
• 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: Female