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 Codes	Emotional Changes (1831); Confusion/ Disorientation (2553)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical study (a4010 vercise dbs registry) patient developed mild hypomania syndrome and was treated with medication.The patient recovered and the event was resolved.The physician assessed the event with a probable relationship to the study procedure, but not related to the study device and stimulation.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical study (a4010 vercise dbs registry) patient developed mild hypomania syndrome and was treated with medication.The patient recovered and the event was resolved.The physician assessed the event with a probable relationship to the study procedure, but not related to the study device and stimulation.Additional information was received that the hypomania event was reported as being related to the right lead only.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical study (a4010 vercise dbs registry) patient developed mild hypomania syndrome and was treated with medication.The patient recovered and the event was resolved.The physician assessed the event with a probable relationship to the study procedure, but not related to the study device and stimulation.Additional information was received that the hypomania event was reported as being related to the right lead only.Additional information was received that the patient also developed symptoms of impulse control disorder and delirium.The patient was recommended to follow-up with outpatient psychiatry.

• 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: 18741422
• Report Number: 3006630150-2024-00837
• Device Sequence Number: 12496077
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2024

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: 06/16/2025
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7081414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 02/14/2024; 04/30/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/07/2024; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2023
• 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: Male