MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise? Cartesia?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-2202-45
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Twitching (2172); Shaking/Tremors (2515); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a narrow therapeutic window associated with lead positioning; however, no lead migration was reported.As the patient's disease progressed, higher stimulation settings were required to adequately control tremor symptoms.Further increases in stimulation amplitude were limited due to side effects related to stimulation, including muscle contractions and persistent paresthesia affecting the hands and face.Programming adjustments were attempted, but no satisfactory solution was achieved.Due to these ongoing issues, the patient underwent replacement of the dbs system.During the procedure, the original burr holes were abandoned, and new burr holes were created to allow placement of the leads along a different trajectory.The explanted devices were retained by the facility and will not be returned for analysis.Postoperatively, the patient was reported to be doing well.
Additional Manufacturer Narrative
B3: no specific event date as inadequate stimulation happened gradually with disease progression.It was on (b)(6) 2025 that the patient was referred to referred to a physician for lead evaluation.D2b: additional pro code selection that applies to the indication of this device: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: 7080422.Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) # (b)(4).Model number/catalog number: db-4600-c.Serial number: n/a.Batch/lot number: 26793897.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) # (b)(4).Model number/catalog number: db-4600-c.Serial number: n/a.Batch/lot number: 26793897.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) # (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a narrow therapeutic window associated with lead positioning; however, no lead migration was reported.As the patient's disease progressed, higher stimulation settings were required to adequately control tremor symptoms.Further increases in stimulation amplitude were limited due to side effects related to stimulation, including muscle contractions and persistent paresthesia affecting the hands and face.Programming adjustments were attempted, but no satisfactory solution was achieved.Due to these ongoing issues, the patient underwent replacement of the dbs system.During the procedure, the original burr holes were abandoned, and new burr holes were created to allow placement of the leads along a different trajectory.The explanted devices were retained by the facility and will not be returned for analysis.Postoperatively, the patient was reported to be doing well.
Additional Manufacturer Narrative
B3: no specific event date as inadequate stimulation happened gradually with disease progression.It was on (b)(6) 2025 that the patient was referred to referred to a physician for lead evaluation.D2b: additional pro code selection that applies to the indication of this device: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: 7080422.Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) # (b)(4).Model number/catalog number: db-4600-c.Serial number: n/a.Batch/lot number: 26793897.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) # (b)(4).Model number/catalog number: db-4600-c.Serial number: n/a.Batch/lot number: 26793897.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) # (b)(4).The burr hole (ln: 26793897) and leads (sn: (b)(6) and (b)(6) were retained by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review did not reveal any anomalies and states that loss of adequate stimulation, weakness, muscle spasms, shaking, restlessness, or problems with movement.Based on all available information, engineers could not determine the root cause for the complaint, therefore concluded the cause could not be established.As patient had 2 burr hole covers with a lot number of 26793897, review of device history record for the second burr hole indicated that the devices met all applicable acceptance criteria and release requirements prior to distribution, and no manufacturing-related nonconformances or deviations were identified that could be associated with the reported event.Review of product labeling identified undesirable sensations such as tingling and weakness, muscle spasms, shaking, restlessness, or problems with movement as known risks associated with therapy.The reported device revision or replacement was considered a secondary outcome of the reported event.As the devices were not returned for analysis, a physical evaluation could not be performed, and the reported allegation could not be confirmed.Evaluation of the available information did not identify objective evidence to determine a cause.Therefore, the investigation conclusion code selected for this investigation is cause not established.

• Brand Name: Vercise? Cartesia?
• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25830616
• Report Number: 3006630150-2026-04965
• Device Sequence Number: 9721336
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)230225(10)7080155
• 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: 2021
• 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,Followup,Followup
• Report Date (Section B): 09/25/2026

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: 02/25/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7080155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 07/24/2026; 09/04/2026; 09/21/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 08/18/2026; 09/08/2026; 09/25/2026
• Date Device Manufactured: 02/25/2021
• 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