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

Model Number	DB-2202-30
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter's phone number is (b)(6); reported here as phone number exceeded character limit for designated field.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced high impedances on contact eight of the right lead wherein causing inadequate stimulation and a return of dystonia symptoms.The patient underwent a revision procedure where the right lead was replaced.The patient was doing well postoperatively.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced high impedances on contact eight of the right lead wherein causing inadequate stimulation and a return of dystonia symptoms.The patient underwent a revision procedure where the right lead was replaced.The patient was doing well postoperatively.Additional information was received indicating the initially reported lead serial number was incorrect.The correct serial number was confirmed and updated.
Additional Manufacturer Narrative
Initial reporter's phone number is (b)(6); reported here as phone number exceeded character limit for designated field.The returned lead was analyzed, passed all tests performed, and exhibited normal device characteristics.A product labeling review identified that the device was used per the instructions for use (ifu) product label.It states failure or malfunction of any of the device components or battery including but not limited to lead or extension breakage, electrical shorts or open circuits and lead insulation breaches can cause loss of adequate stimulation and motor problems such as tremor, dystonia, or dyskinesias and may result in an explant or reimplantation and are known risks with the use of deep brain stimulation (dbs).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced high impedances on contact eight of the right lead wherein causing inadequate stimulation and a return of dystonia symptoms.The patient underwent a revision procedure where the right lead was replaced.The patient was doing well postoperatively.Additional information was received indicating the initially reported lead serial number was incorrect.The correct serial number was confirmed and updated.

• 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: 21769718
• Report Number: 3006630150-2025-02124
• Device Sequence Number: 18164484
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: (01)08714729905271(17)240723(10)7077619(21)7077619
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2025

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 Expiration Date: 07/23/2024
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7077619
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 05/15/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2022
• 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
• Patient Sex: Unknown