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

Model Number	DB-2203-45
Medical Device Problem Codes	High impedance (1291); Difficult to Insert (1316); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-extension upn: m365db3216550 model: db-3216-55 serial: (b)(6) batch: 5001716 udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient was evaluated in clinic for device reprogramming due to recurrence of tremor in the right hand.High impedance measurements were observed during the assessment.The patient reported experiencing several falls, one of which required a visit to urgent care.These incidents were not believed to be related to the dbs device but may have contributed to the impedance issue.Imaging of the lead and lead extension site revealed a misalignment at the connection.The surgeon opted to manipulate the extension connection through the skin, under x-ray guidance.Proper alignment between the lead and extension was confirmed through imaging and impedance testing via the implantable pulse generator (ipg).Following the procedure, impedance levels were within normal range.The patient is receiving effective therapy with good symptom control.The patient was discharged home and continues to do well.No device return is expected, as the device remains implanted.

• Brand Name: VERCISE? CARTESIA? X
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: 23918953
• Report Number: 3006630150-2025-11757
• Device Sequence Number: 9013129
• Product Code: PJS
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)270309(10)5003189
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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 Model Number: DB-2203-45
• Device Catalogue Number: DB-2203-45
• Device Lot Number: 5003189
• 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: 06/20/2025
• Initial Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 03/09/2025
• 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: 74 YR
• Patient Sex: Female
• Patient Race: White