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 Hematoma (1884); Paralysis (1997)

Event Date 07/24/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a deep brain stimulation (dbs) stage one lead implant procedure.The procedure was successful, and the scans did not show any bleeding.Two days later the patient was instructed by his cardiologist to re-start his anticoagulant medication, lovenox.A few days later the patient experienced stroke like symptoms of confusion, paralysis and alertness, and therefore was admitted to the hospital where a hematoma was discovered.The patient underwent a hematoma evacuation procedure, and the left lead and burr hole cover were explanted.The right lead remains implanted and there will be no further course of action regarding the right lead.The physician assessed that the event was not device or procedure related, rather it was due to the patient being instructed to begin taking the lovenox medication too early.Due to the hematoma the patient experienced paralysis and was not conscious.The patient was released from the hospital, and the paralysis has resolved.The patient was at a rehabilitation facility, gaining strength and functions back, and is now at a hospice care facility.The explanted devices will not be returned as they were disposed at the facility.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family dbs-linear leads, upn m365db2202450, model db-2202-45, serial (b)(6), batch 7105092.Product family dbs-lead fixation, upn m354db4600c0, model db4600c, lot 31573515, batch 31573515.

• 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: 17571883
• MDR Text Key: 321417090
• Report Number: 3006630150-2023-04879
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2023

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 Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7107449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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; Disability
• Patient Age: 78 YR
• Patient Sex: Male