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

Model Number 2102

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

Patient Problems Arrhythmia (1721); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/01/2022

Event Type  Death  

Event Description

A patient was hospitalized with severe heart failure, and reported a syncopal episode and arrhythmia on (b)(6) 2022.The patient had been at 4ma, and was not doing as well, so the physician asked that the barostim therapy be decreased from 4ma to 2 ma on (b)(6) 2022.The patient continued to deteriorate, and therapy was further decreased from 2ma to 1ma on (b)(6) 2022.The patient coded and was resuscitated the night of (b)(6) 2022.The physician was unable to determine what caused syncopal episode and other symptoms.It was noted that the patient was non-compliant with medications and had not been taking them for approximately one week prior to the hospitalization.The patient did have an icd for rate support.

Manufacturer Narrative

The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record and sterilization 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).

Event Description

A patient was hospitalized with severe heart failure, and reported a syncopal episode and arrhythmia on (b)(6) 2022.The patient had been at 4ma, and was not doing as well, so the physician asked that the barostim therapy be decreased from 4ma to 2 ma on ( b)(6) 2022.The patient continued to deteriorate, and therapy was further decreased from 2ma to 1ma on (b)(6) 2022.The patient coded and was resuscitated the night of (b)(6) 2022.The physician was unable to determine what caused syncopal episode and other symptoms.It was noted that the patient was non-compliant with medications and had not been taking them for approximately one week prior to the hospitalization.The patient did have an icd for rate support.On (b)(6) 2023, it was reported that the patient had experienced cardiogenic shock in (b)(6) 2023, was put on comfort care, and passed away.Additional information, including date and cause of death were not available.

Manufacturer Narrative

Updated fields: b2, b4, b5, g3, g6, h1, h2, h6, h10 a post-review of the event was performed by a medical reviewer.The physician did not see a likely association between the event and barostim device or therapy.Cvrx id# (b)(4).

• Brand Name: BAROSTIM NEO
• 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: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 16077332
• MDR Text Key: 306416448
• Report Number: 3007972010-2022-00024
• Device Sequence Number: 1
• Product Code: DSR
• 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,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2023
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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; Death; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male