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); Off-Label Use (1494); Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Movement Disorder (4412); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
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: m365db312855b0, model: db-3128-55b, serial: (b)(6), batch: 5003893, udi: (b)(4).Product family: dbs-extension upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7077384, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure where in the implantable pulse generator (ipg), and lead extensions were revised for an unknown reason.
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: m365db312855b0 model: db-3128-55b serial: (b)(6).Batch: 5003893 udi: (b)(4).Product family: dbs-extension upn: m365nm3138550 model: nm-3138-55 serial: (b)(6).Batch: 7077384 udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure where in the implantable pulse generator (ipg), and lead extensions were revised for an unknown reason.Additional information indicated the deep brain stimulation (dbs) pediatric patient underwent an explant procedure due to high impedances observed on both leads.According to the treating physician, these high impedances were likely caused by excessive head movements.The patient had previously experienced elevated impedance levels, which were managed through device reprogramming.However, the issue progressively worsened, ultimately resulting in inadequate stimulation.Post operatively the patient is doing great, with therapy restore and improved.The explanted device will be returned for further analysis.
Additional Manufacturer Narrative
The device returned for analysis was model db-1200-s, serial number (b)(6).Comprehensive evaluation of the returned ipg was performed.The implantable pulse generator (ipg) passed visual inspection and the functional test without any anomalies.No impedance anomalies were observed when measured on the remote control or during the functional test.However, observations from the treating physician in the field, noted the high impedances were likely caused by the excessive head movements of the pediatric patient.A labeling review was also conducted, and reveals the reported event is a known risk associated with the use of an ipg as part of a system to deliver deep brain stimulation.Correction to the follow-up 1 mdr in block(s) h11.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: 7077381.Udi: (b)(4).Product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7077384.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure where in the implantable pulse generator (ipg), and lead extensions were revised for an unknown reason.Additional information indicated the deep brain stimulation (dbs) pediatric patient underwent an explant procedure due to high impedances observed on both leads.According to the treating physician, these high impedances were likely caused by excessive head movements.The patient had previously experienced elevated impedance levels, which were managed through device reprogramming.However, the issue progressively worsened, ultimately resulting in inadequate stimulation.Post operatively the patient is doing great, with therapy restore and improved.The explanted device will be returned for further analysis.
Additional Manufacturer Narrative
The device returned for analysis was model nm-3138-55, serial number (b)(6).Comprehensive evaluation of the returned leads was performed.The visual inspection revealed that the lead was cleanly cut into two pieces approximately 23 cm from the lead extension connector and the proximal end of the lead is not returned.The clean-cut damage is a result of a typical explant procedure, and it is not considered a failure.No other anomalies were identified on the returned portion of the lead aside from the clean-cut.However, a labelling review found that the reported event is a known risk with the use of deep brain stimulation (dbs).The device returned for analysis was model db-1200-s, serial number (b)(6).Comprehensive evaluation of the returned ipg was performed.The implantable pulse generator (ipg) passed visual inspection and the functional test without any anomalies.No impedance anomalies were observed when measured on the remote control or during the functional test.However, observations from the treating physician in the field, noted the high impedances were likely caused by the excessive head movements of the pediatric patient.A labeling review was also conducted, and reveals the reported event is a known risk associated with the use of an ipg as part of a system to deliver deep brain stimulation.Correction to the follow-up 1 mdr in block(s) h11.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: 7077381 udi:(b)(4).Product family: dbs-extension upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7077384, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure where in the implantable pulse generator (ipg), and lead extensions were revised for an unknown reason.Additional information indicated the deep brain stimulation (dbs) pediatric patient underwent an explant procedure due to high impedances observed on both leads.According to the treating physician, these high impedances were likely caused by excessive head movements.The patient had previously experienced elevated impedance levels, which were managed through device reprogramming.However, the issue progressively worsened, ultimately resulting in inadequate stimulation.Post operatively the patient is doing great, with therapy restore and improved.The explanted device will be returned for further analysis.

• 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 CA 91355 ; CS 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23139996
• Report Number: 3006630150-2025-07995
• Device Sequence Number: 9916319
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)220710(10)743340
• 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: 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,Followup,Followup
• Report Date (Section B): 03/01/2026

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: 07/10/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 743340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 01/16/2026; 02/02/2026
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/15/2025; 02/10/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2020
• 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: 17 YR
• Patient Sex: Male