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

Model Number DB-2202-30

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

Patient Problems Emotional Changes (1831); Confusion/ Disorientation (2553)

Event Date 11/22/2023

Event Type  Injury  

Event 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 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 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
• 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: 18741422
• MDR Text Key: 335778114
• Report Number: 3006630150-2024-00837
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 02/14/2024; 04/30/2024
• Supplement Dates FDA Received: 03/07/2024; 05/03/2024
• 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): Required Intervention
• Patient Sex: Male