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 Emotional Changes (1831); Cerebral Edema (4403); Swelling/ Edema (4577)

Event Date 03/15/2022

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation patient developed agitation as well as moderate frontal right cerebral edema eight days post implant procedure.The patient was admitted to the hospital where medication was administered.The reported event is unresolved.The physician assessed the event as having had a probable relationship to the procedure and device hardware and was not stimulation related.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads upn: m365db2202450.Model: db-2202-45.Serial: (b)(4).Batch: 7081862.

Event Description

It was reported that the deep brain stimulation patient (clinical study number (b)(6) ) developed agitation as well as moderate frontal right cerebral edema eight days post implant procedure.The patient was admitted to the hospital where medication was administered.The reported event is unresolved.The physician assessed the event as having had a probable relationship to the procedure and device hardware and was not stimulation related.Additional information was received that the patient was treated with high-dose steroid therapy to be continued at home and has been discharged.

• 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: 14156322
• MDR Text Key: 289605359
• Report Number: 3006630150-2022-01732
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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: 04/27/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7081673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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; Hospitalization
• Patient Sex: Male