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

Model Number	DB-2202-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a large lead edema a few days following the lead implantation procedure.The edema was confirmed via computerized tomography (ct) scan to be located along the lead.The devices remained implanted, and the patient was treated with medication.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: (b)(6).

• Brand Name: VERCISE CARTESIA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 17874030
• Report Number: 3006630150-2023-06038
• Device Sequence Number: 11842472
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 10/04/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/27/2024
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7078354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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 Age: 70 YR
• Patient Sex: Male