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 Dyspnea (1816); Fatigue (1849); Muscle Weakness (1967); Tachycardia (2095)

Event Date 04/19/2023

Event Type  Death  

Manufacturer Narrative

While analysis was unable to be performed as the device was not returned, per the opinion of the managing physician, this event was due to the pre-existing patient condition and was not related to the barostim device or implant procedure.The barostim system was left activated at a subtherapeutic rate of 1.0ma after implant and was not reprogrammed before the event, supporting the physician's opinion that the event was not related to the barostim system.There is no alleged malfunction against a cvrx device or implant, therefore this event does not meet the definition of a complaint.An outside physician consultant did not identify an alleged malfunction against the cvrx device or implant.The device history 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 barostim system was implanted on (b)(6) 2023.The barostim system was left activated at a subtherapeutic rate of 1.0ma.On (b)(6) 2023, the patient presented to the emergency room with shortness of breath, fatigue, weakness, and rapid heartbeat.The patient was subsequently admitted for heart failure exacerbation.Reducing fluid volume and loop diuretics were planned, however, the patient passed away.No therapy adjustments had been made to the barostim system between implant and 19-apr-2023.In the opinion of the physician, the cause of the hf exacerbation was due to the patient having class iv hf with advanced heart failure symptoms.The physician stated the hf exacerbation was not related to the barostim device or implant procedure.

• 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: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 16946931
• MDR Text Key: 315393295
• Report Number: 3007972010-2023-00018
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)240330
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• 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: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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; Death
• Patient Age: 77 YR
• Patient Sex: Male