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

Model Number	DB-2201-45DC
Medical Device Problem Codes	Off-Label Use (1494); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: unk-m-db-2202-45 model: db-2202-45 serial: na.Batch: na udi: na.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure due to the leads not providing therapy.The patient is being treated for central pain post-stroke.The leads were replaced, and the patient is still in the hospital recovering.The explanted devices will not be returned to boston scientific for analysis, as they were destroyed by the facility.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure due to the leads not providing therapy.The patient is being treated for central pain post-stroke.The leads were replaced, and the patient is still in the hospital recovering.The explanted devices will not be returned to boston scientific for analysis, as they were destroyed by the facility.Additional information was received providing the patient's information and product details.
Additional Manufacturer Narrative
Correction to: block h6.Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: m365db220145dc0, model: db-2201-45dc, serial: (b)(6), batch: 7072525, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure due to the leads not providing therapy.The patient is being treated for central pain post-stroke.The leads were replaced, and the patient is still in the hospital recovering.The explanted devices will not be returned to boston scientific for analysis, as they were destroyed by the facility.Additional information was received providing the patient's information and product details.
Additional Manufacturer Narrative
This report is being submitted to correct the unique identifier (udi) # field (d4) in section d, suspect medical device.Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db220145dc0.Model: db-2201-45dc.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).

• 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23216118
• Report Number: 3006630150-2025-08366
• Device Sequence Number: 15683140
• Product Code: MHY
• 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: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2026

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: 02/18/2024
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 7072343
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/05/2025; 05/19/2026
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 10/07/2025; 05/19/2026
• Date Device Manufactured: 02/18/2022
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male