MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE GEVIA?; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-1200-S
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Paresthesia (4421); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7053789.Udi:(b)(4).Product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7054143.Udi: (b)(4).
Event or Problem Description
It was reported that this deep brain stimulation (dbs) system was replaced due to an unknown reason.The location of the device is unknown.No additional adverse patient effects were reported despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-extension upn: m365nm3138550 model: nm-3138-55 serial: (b)(6).Batch: 7053789 udi: (b)(4).Product family: dbs-extension upn: m365nm3138550 model: nm-3138-55 serial: (b)(6).Batch: 7054143 udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a system explant due to high impedances.The patient's symptoms included a return of tremor, as well as transient tingling on the left side of their mouth when turning their head.The patient is stable postoperatively and symptoms are well controlled.The explanted devices will not be returned to boston scientific for analysis, as they were retained by the hospital.
Additional Manufacturer Narrative
Correction to blocks: a6, b5, d2b, e1, h2, h11.Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7053789, udi: (b)(4).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7054143, udi: (b)(4).
Event or Problem Description
Additional information received stated that the dbs patient underwent a system explant due to high impedances.The patient's symptoms included a return of tremor, as well as transient tingling on the left side of their mouth when turning their head.The patient is stable postoperatively and symptoms are well controlled.The explanted devices will not be returned to boston scientific for analysis, as they were retained by the hospital.

• 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 ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22688670
• Report Number: 3006630150-2025-06079
• Device Sequence Number: 20580749
• Product Code: PJS
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)210610(10)738867
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/10/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 738867
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 03/13/2026
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/12/2025; 03/13/2026
• Date Device Manufactured: 06/11/2019
• 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: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Race: White