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	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure for an unknown reason.The current location of the device remains unknown.No additional adverse patient effects were reported, and no additional information was available.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional pro code selection that applies to the indication of this device nhl, pjs: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7081809, udi: (b)(4).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7081598, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4605c0, model: db-4605-c, batch: 24900562, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4605c0, model: db-4605-c, batch: 25871625, udi: (b)(4).Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure for an unknown reason.The current location of the device remains unknown.No additional adverse patient effects were reported, and no additional information was available.Additional information confirms that the patient underwent a deep brain stimulation (dbs) explant procedure due to suboptimal lead placement, resulting in inadequate stimulation.The attending physician verified that the lead had been improperly positioned.Despite good faith efforts, the explant reasons for the implantable pulse generator (ipg), lead extension, and burr hole cover remain unknown.Postoperatively, the patient is recovering well without complications.In accordance with facility policy, the explanted device has been retained and will not be returned.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional pro code selection that applies to the indication of this device .Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7081809, udi: (b)(4).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7081598, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4605c0, model: db-4605-c, batch: 24900562, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4605c0, model: db-4605-c, batch: 25871625, udi: (b)(4).Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7076997, 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 91355 ; * 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22564278
• Report Number: 3006630150-2025-05734
• Device Sequence Number: 3904068
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)221111(10)745089
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 08/28/2025

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: 11/11/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 745089
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 11/11/2020
• 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: 58 YR
• Patient Sex: Male