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	08/16/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient has died for an unknown reason.The patients sister reported that the death was expected and not related to dbs or essential tremor for which the dbs system was indicated.The physician had no information to provide regarding the death.
Additional Manufacturer Narrative
Additional product(s) in device system: model number/catalog number: db-2202-45 serial number: 7101428 batch/lot number: 7101428 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #: (b)(4).Model number/catalog number: db-2202-45 serial number: 7101480 batch/lot number: 7101480 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #: (b)(4).Model number/catalog number: db-4600-c serial number: n/a batch/lot number: 30853160 model/catalog description: suretek burr hole cover kit unique identifier (udi) #: (01)08714729820802(17)250126(10)30853160 model number/catalog number: db-4605-c serial number: n/a batch/lot number: 29705274 model/catalog description: dbs burr hole cover spares kit unique identifier (udi) #:(b)(4).Model number/catalog number: db-4605-c serial number: n/a batch/lot number: 30576896 model/catalog description: dbs burr hole cover spares kit unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55 serial number: 7107792 batch/lot number: 7107792 model/catalog description: 55cm 8 contact extension unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55 serial number: 7110672 batch/lot number: 7110672 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: 50736519
• Report Number: 3006630150-2026-06684
• Device Sequence Number: 13421594
• Product Code: PJS
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)250131(10)561913
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/11/2026

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: 01/31/2025
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 561913
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 02/01/2023
• 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: 79 YR
• Patient Sex: Female