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

Model Number DB-2202-45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 07/19/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a successful stage one implantation procedure in which bilateral leads were placed.The patient stayed overnight and was discharged the second day without any visible complications related to the surgery.While at home, between stage one and stage 2 cases, the patient started experiencing complications.It was assessed that the patient had a cerebral vascular accident (cva).He is currently hospitalized and undergoing treatment, and the patient is slightly improving.The stage 2 procedure was postponed as a result.

Event Description

It was reported that the patient underwent a successful stage one implantation procedure in which bilateral leads were placed.The patient stayed overnight and was discharged the second day without any visible complications related to the surgery.While at home, between stage one and stage 2 cases, the patient started experiencing complications.It was assessed that the patient had a cerebral vascular accident (cva).He is currently hospitalized and undergoing treatment, and the patient is slightly improving.The stage 2 procedure was postponed as a result.Additional information was received that the patient was admitted into in-patient rehabilitation.

• Brand Name: VERCISE CARTESIA
• Type of Device: 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: 17570954
• MDR Text Key: 321402968
• Report Number: 3006630150-2023-04870
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7106622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male