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 Stroke/CVA (1770); Hematoma (1884); Intracranial Hemorrhage (1891); Confusion/ Disorientation (2553); Movement Disorder (4412); Speech Disorder (4415)

Event Date 02/07/2022

Event Type  Injury  

Event Description

It was reported that the patient, that is enrolled in the a4010 clinical study, suffered a stroke during the implant procedure.The patient was treated with medication and his hospitalization was prolonged.The event was reported as having a causal relationship to the procedure and not related to the device or the stimulation.

Event Description

It was reported that the patient, that is enrolled in the (b)(6) clinical study, suffered a stroke during the implant procedure of the left lead.The patient was treated with medication and his hospitalization was prolonged.A ct scan, computerized tomography scan was performed post op and no anomalies were noted.The left lead was removed after the ct scan showed it was suboptimal in location and a new lead was implanted.The patient later developed confusion, speech slowing, dysarthria, and balance disturbance post-operatively, a second ct scan was performed four days after the initial implant, and it showed oedema and acute hemorrhage in the superficial left frontal lobe at the entry point of the lead and some small volume hematoma around the tip of the lead.The patient was admitted and kept under observation for three weeks as he slowly and gradually recovered.The patient was transferred to another hospital for ongoing rehabilitation.The patient and the event are recovering and resolving.The event was reported as having a causal relationship to the procedure and not related to the device or the stimulation.

• 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 tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14596665
• MDR Text Key: 293302342
• Report Number: 3006630150-2022-02686
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/05/2022

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: 09/26/2023
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7075578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2021
• 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