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

Model Number	DB-2202-45
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Use of Device Problem (1670)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records associated with these devices indicated that they were successfully processed according to requirements.The dhr did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.Physical analysis could not be completed in our laboratory, as the devices were retained by the medical facility and were not returned.A labelling review was performed based on the dfu and it did not reveal any anomalies as it states a loss of adequate stimulation, weakness, muscle spasms, shaking, restlessness, or problems with movement are known risks with the use of deep brain stimulation (dbs).The devices were not returned as they were retained by the medical facility.As such, physical analysis has not been conducted in our laboratory, and the reported allegation of inadequate stimulation and device damaged during surgery could not be confirmed.Additionally, a record review was performed and revealed no additional information related the complaint and therefore a root cause of the event could not be established.
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) revision procedure to replace the right-side lead due to non optimal placement and lack of tremor control, a plasma blade was utilized.Following the placement of the new lead an impedance check indicated all contacts were open.After further troubleshooting it was discovered that the implantable pulse generator (ipg) had been compromised and was no longer functional.The ipg was also replaced.The patient was doing was doing well postoperatively.The explanted devices were retained by the medical facility and were not returned.

• 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: 25292596
• Report Number: 3006630150-2026-03510
• Device Sequence Number: 9319286
• Product Code: PJS
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)230720(10)7084604
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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: 07/20/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7084604
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 07/20/2021
• 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: 60 YR
• Patient Sex: Female