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

Model Number	DB-3128-55B
Medical Device Problem Codes	High impedance (1291); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the second stage of the deep brain stimulation (dbs) procedure, the physician encountered a high impedance on the lead extension and difficulties removing it from left brain lead.Attempts to remove the lead extension using saline, oil and other surgical tools was performed however were unsuccessful.The physician assessed that the lead extension set screw was damaged while pulling it down the neckline which clamped down on the lead as a result was unable to be disconnected.The physician opted to cut the lead, leaving it attached to the damaged lead extension therefore aborted the lead extension implant procedure.The patient did well post-operatively.
Additional Manufacturer Narrative
Block d2b: additional pro codes, nhl, pjs.Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: m365db2202450 model: db-2202-45 serial: (b)(6).Batch: 7125000 udi: (b)(4).
Additional Manufacturer Narrative
Blocks h9 correction/removal reporting number and h10 related report number: updated, received fda letter.
Event or Problem Description
It was reported that during the second stage of the deep brain stimulation (dbs) procedure, the physician encountered a high impedance on the lead extension and difficulties removing it from left brain lead.Attempts to remove the lead extension using saline, oil and other surgical tools was performed however were unsuccessful.The physician assessed that the lead extension set screw was damaged while pulling it down the neckline which clamped down on the lead as a result was unable to be disconnected.The physician opted to cut the lead, leaving it attached to the damaged lead extension therefore aborted the lead extension implant procedure.The patient did well post-operatively.
Additional Manufacturer Narrative
Analysis of the returned vercise lead extension visual inspection revealed one side of the extension connector was separated likely caused by the physicians attempt to remove the lead proximal array.Additionally, a portion of the attached lead revealed contact number eight has a set screw mark causing deformation to that contact.This type of damage is a result by the set screw being tightened prior to properly inserting lead into lead extension resulting in inability to separate devices.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states visually check that the dbs lead electrodes are aligned with the lead extension contacts.With all the available information, boston scientific concludes the inability to remove lead from lead extension and high impedance reported event was confirmed.Ifu indicates user to ensure the lead be fully inserted into lead extension connector before tightening the set screw.Therefore, engineers concluded the probable cause selected is unintended use error caused or contributed to the event.Section e1 initial reporter email updated.
Event or Problem Description
It was reported that during the second stage of the deep brain stimulation (dbs) procedure, the physician encountered a high impedance on the lead extension and difficulties removing it from left brain lead.Attempts to remove the lead extension using saline, oil and other surgical tools was performed however were unsuccessful.The physician assessed that the lead extension set screw was damaged while pulling it down the neckline which clamped down on the lead as a result was unable to be disconnected.The physician opted to cut the lead, leaving it attached to the damaged lead extension therefore aborted the lead extension implant procedure.The patient did well post-operatively.

• 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: 22215935
• Report Number: 2124215-2025-39653
• Device Sequence Number: 8157867
• Product Code: MHY
• UDI-Device Identifier: 00191506023577
• UDI-Public: (01)00191506023577(17)260908(10)5003418
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2026
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5003418
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 10/24/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/18/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2300380000-2025-8028
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female