MAUDE Adverse Event Report: CVRX, INC BAROSTIM NEO2; IMPLANTABLE PULSE GENERATOR

Model Number 2104

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Speech Disorder (4415); Embolism/Embolus (4438)

Event Date 12/22/2023

Event Type  Death  

Event Description

On (b)(6) 2023, barostim device was implanted, and the patient was sent home.On 27-dec-2023, it was reported that on (b)(6) 2023, the patient suffered a stroke and was admitted to the hospital.It was reported that the physicians believe that the event might have been caused from stopping the patient's blood thinners during their implant procedure.The patient has a blood clot in their brain and was not able to receive medication because of their heart condition.Emergency surgery was performed to remove the blood clot which was successful.The patient was on a vent and when they tried to remove the vent, the patient failed the breathing test and was non-verbal.Physicians informed the patient family that the patient will not recover without being on breathing machines and being fed by feeding tubes.They opted not to do that and as of (b)(6) 2023, the patient was in hospice.The patient expired on (b)(6) 2023.Per the opinion of the physician as of 04-jan-2023, the root cause of the event was unknown.

Manufacturer Narrative

While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was unknown but believed it might have been caused from stopping the patients' blood thinners during the implant procedure.The device history record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Cvrx id# (b)(4).

• Brand Name: BAROSTIM NEO2
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer (Section G): CVRX, INC; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 18590003
• MDR Text Key: 333862573
• Report Number: 3007972010-2023-00063
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)240616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180050
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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; Disability; Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White