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 Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Cognitive Changes (2551)

Event Date 10/28/2022

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a severe postoperative hemorrhage in the left frontal lobe of the brain near the lead site after the dbs implant procedure.The patient also experienced symptoms of delayed cognitive and verbal processing.Therefore, the patient was treated with medication and underwent a computerized tomography (ct) scan.The hemorrhage was assessed to have a causal relationship to the procedure and the hardware, but not related to stimulation.The patient has since recovered and symptoms have resolved.Additionally, the patient experienced a mild local infection in the right forearm which was treated with antibiotics.The infection was assessed to be associated with the venous catheter and had a causal relationship to the procedure, but not related to stimulation or hardware.The skin infection event remains unresolved.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a severe postoperative hemorrhage in the left frontal lobe of the brain near the lead site after the dbs implant procedure.The patient also experienced symptoms of delayed cognitive and verbal processing.Therefore, the patient was treated with medication and underwent a computerized tomography (ct) scan.The hemorrhage was assessed to have a causal relationship to the procedure and the hardware, but not related to stimulation.The patient has since recovered and symptoms have resolved.Additionally, the patient experienced a mild local infection in the right forearm which was treated with antibiotics.The infection was assessed to be associated with the venous catheter and had a causal relationship to the procedure, but not related to stimulation or hardware.The skin infection event remains unresolved.Additional information was received that the patient had experienced a fever.Also, the ct scan confirmed there was bleeding in the left frontal region of the brain along the lead.A second ct scan a few days later showed a reabsorption bleed.Both the hemorrhage and skin infection events have resolved and the patient has recovered.

Manufacturer Narrative

Correction to block h6: impact codes.Updates to block b5 and block h6: patient codes.

• 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: 15821149
• MDR Text Key: 303895102
• Report Number: 3006630150-2022-06336
• 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
• Report Date: 01/09/2023

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 Expiration Date: 11/11/2023
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7076087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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 Age: 70 YR
• Patient Sex: Male