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); Intracranial Hemorrhage (1891); Twitching (2172); Cognitive Changes (2551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/23/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced moderate bleeding around the left electrode post-operatively.It is unknown which lead was on the left.The patient was treated with medication and is doing well.

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).

Event Description

It was reported that after a deep brain stimulation lead implant procedure, the patient experienced moderate intracranial bleeding around the left electrode post-operatively.The patient was treated with medication and is doing well.

Manufacturer Narrative

Update in block: h6.

Event Description

It was reported that after a deep brain stimulation lead implant procedure, the patient experienced moderate intracranial bleeding around the left electrode post-operatively.The patient was treated with medication and is doing well.

Event Description

It was reported that after a deep brain stimulation lead implant procedure, the patient experienced moderate intracranial bleeding around the left electrode post-operatively.The patient was treated with medication and is doing well.Additional information was received that the patient experienced minor intracranial bleeding around the left electrode post-operatively.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12200514
• MDR Text Key: 262620076
• Report Number: 3006630150-2021-03926
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2022

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 Expiration Date: 01/14/2023
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7073442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/12/2021; 12/14/2021; 10/07/2022
• Supplement Dates FDA Received: 09/03/2021; 01/11/2022; 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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