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 Problems Dysphasia (2195); Cognitive Changes (2551); Confusion/ Disorientation (2553); Movement Disorder (4412); Swelling/ Edema (4577)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown, event occurred between (b)(6) 2023 - (b)(6) 2023.

Event Description

It was reported that a deep brain stimulation (dbs) patient experienced confusion, speech, balance, walking and cognitive difficulties after the dbs lead implant procedure.A computed tomography (ct) image taken revealed an edema located in the interior left frontal lobe that may have been attributed to the procedure per the physicians assessment.A microelectrode recording (mer) was performed on the symptomatic edema and non-symptomatic side, however the results are unknown.Steroids were prescribed and the patient continues under the care of his physician.

• 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: 17836520
• MDR Text Key: 324508088
• Report Number: 3006630150-2023-05892
• 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
• Report Date: 09/28/2023

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: 7105177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: White