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

Model Number	NM-3138-55
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Scar Tissue (2060); Discomfort (2330)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7080663, udi: (b)(4).
Event or Problem Description
It was reported that during functional testing, high impedances were identified on the deep brain stimulation (dbs) device.Clinical evaluation indicated that scar tissue had formed around the lead extensions, causing bowstringing and resulting in cervical spine discomfort due to reduced range of motion.The patient underwent a procedure to replace the lead extensions, which was completed successfully.The patient did well post-operatively.
Event or Problem Description
It was reported that during functional testing, high impedances were identified on the deep brain stimulation (dbs) device.Clinical evaluation indicated that scar tissue had formed around the lead extensions, causing bowstringing and resulting in cervical spine discomfort due to reduced range of motion.The patient underwent a procedure to replace the lead extensions, which was completed successfully.The patient did well post-operatively.
Additional Manufacturer Narrative
The returned dbs lead extension serial number (b)(6) was analyzed, passed all tests performed, and exhibited normal characteristics.A labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states discomfort and fibrosis such as thickened skin and scarring around the lead extension are known risks with the use of the dbs.The reported event was not confirmed for the high impedance.With all the available information, boston scientific concludes probable cause was no problem detected, the returned dbs lead extension serial number (b)(6) was analyzed, and x-ray inspection revealed two cables were fractured after the weld in the distal connector stack, however remained contained inside connector, this type of damage occurs when excessive when excessive tensile force is exerted onto the lead extension body and connector sections.The reported event of high impedances was confirmed therefore boston scientific concludes probable cause was caused traced to component failure, a labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states failure or malfunction of any of the device components or the battery, including but not limited to the lead extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, whether or not this requires surgical intervention, including discomfort and fibrosis such as thickened skin and scarring around the lead extension are known risks with the use of the dbs.

• Brand Name: VERCISE
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22709252
• Report Number: 3006630150-2025-06145
• Device Sequence Number: 18370641
• Product Code: NHL
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)221012(10)7080709
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/12/2022
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7080709
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• 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: 61 YR
• Patient Sex: Male