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

Model Number	DB-2201-45DC
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Discomfort (2330)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event unknown.Approximated past year prior the manufacturer becoming aware of the event.Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: m365db220145dc0 model: db-2201-45dc serial: (b)(6) batch: 679210 udi: ((b)(4).Product family: dbs-lead fixation upn: m365db4600c0 model: db-4600-c serial: n/a batch: 21964610 udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced uncomfortable stimulation sensations while the implantable pulse generator (ipg) was active.Reprogramming attempts were unsuccessful.The physician determined that the patient would benefit from a hardware upgrade and lead repositioning.The patient subsequently underwent a procedure in which the existing leads and burr hole covers (bhc) were removed and replaced with a new bhc and different model leads placed in an alternative target.Device analysis was not conducted, as the components were retained by the facility.The patient recovered well following the procedure.
Additional Manufacturer Narrative
With all the available information, in the absence of the devices being returned, the reported event of patient experiencing undesired stimulation sensations is a known inherent risk with use of the devices, as documented in the instructions for use (ifu).A review of the manufacturing documentation for the dbs devices revealed that no anomalies or deviations related to the event occurred during manufacturing.The devices were retained by the facility and not returned for analysis; therefore, a physical analysis has not been conducted in our laboratory.However, labeling review was conducted.A product labeling review identified that the devices were used per the ifu product labels.Additionally, undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure, all of which are noted within the ifu as known inherent risks associated with use of the devices.The dbs devices were retained by the facility and not returned.As such, physical analysis has not been conducted in our laboratory.However, the labeling review was conducted.With the reported observations and the labeling review, it has been determined that undesired stimulation sensations is a known inherent risk with use of the devices as documented in the ifu.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db220145dc0, model: db-2201-45dc, serial: (b)(6), batch: 679210, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600-c, serial: n/a, batch: 21964610, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced uncomfortable stimulation sensations while the implantable pulse generator (ipg) was active.Reprogramming attempts were unsuccessful.The physician determined that the patient would benefit from a hardware upgrade and lead repositioning.The patient subsequently underwent a procedure in which the existing leads and burr hole covers (bhc) were removed and replaced with a new bhc and different model leads placed in an alternative target.Device analysis was not conducted, as the components were retained by the facility.The patient recovered well following the procedure.

• 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: 24372789
• Report Number: 3006630150-2026-00946
• Device Sequence Number: 4875368
• Product Code: NHL
• UDI-Device Identifier: 08714729836544
• UDI-Public: (01)08714729836544(17)200221(10)679237
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• 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): 04/01/2026

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: 02/21/2020
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 679237
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 02/21/2018
• 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: 70 YR
• Patient Sex: Female