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 Pulmonary Embolism (1498); No Code Available (3191)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-30, serial: (b)(4), batch: 5116865.

Event Description

It was reported that the patient experienced chest pain post dbs trial implant procedure.A chest ct revealed a pulmonary embolism.The patient was treated in the icu and was transferred to the normal ward in stable condition.After initial iv administration of heparin, anticoagulation was continued with subcutaneous injection heparin.An endoscopic biopsy of a tumor suspicious lesion in the chest was performed.Histologically no tumor was detected in the specimen.A transthoracic echocardiographic follow up examination continued to show no increased right heart load.The anticoagulation was continued with oral rivaroxaban.The patient was discharged from the hospital on (b)(6) 2020 and will continue anticoagulation treatment for 3 months.The patient will be reevaluated via electrocardiography, and duplex ultrasound, post 3 month anticoagulation treatment.Pulmonary embolism was possibly related to the procedure and not related to the device.

• 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; RQ 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11175547
• MDR Text Key: 226993395
• Report Number: 3006630150-2020-06672
• 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: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

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: 01/11/2021
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 5117528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2019
• 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): Hospitalization; Required Intervention