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

Model Number	DB-1416
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	06/16/2026
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 d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-9218-15.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: vercise m8 adapter 15cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-9218-15.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: vercise m8 adapter 15cm.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: 50599425
• Report Number: 3006630150-2026-06381
• Device Sequence Number: 10225407
• Product Code: MHY
• UDI-Device Identifier: 08714729985020
• UDI-Public: (01)08714729985020(17)230616(10)204589
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 06/16/2023
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 204589
• 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: 09/03/2026
• Date Device Manufactured: 06/16/2021
• 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: Male