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

Model Number	DB-1200-S
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	07/27/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient passed away.The cause of death is unknown.No further information has been obtained.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient passed away.The cause of death is unknown.No further information has been obtained.Additional information was received indicating that the dbs patient was ill, and it was noted that the patient had diabetes and was overweight.The cause of death is not believed to be device related; however, it remains unconfirmed.
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 - nhl, pjs.Additional product(s) in device system: model number/catalog number: db-9218-15, serial number: (b)(6), batch/lot number: 7052659, 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: 7052662, model/catalog description: vercise m8 adapter 15cm, unique identifier (udi) #: (b)(4).
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-9218-15, serial number: (b)(6), batch/lot number: 7052659, 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: 7052662, model/catalog description: vercise m8 adapter 15cm, unique identifier (udi) #: (b)(4).

• Brand Name: Vercise Gevia?
• 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: 50333773
• Report Number: 3006630150-2026-06061
• Device Sequence Number: 17500613
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)210507(10)738346
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 05/07/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 738346
• 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
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 05/08/2019
• 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: 78 YR
• Patient Sex: Female