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); Pneumonia (2011); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/13/2024

Event Type  Death  

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 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.H6: health effect - impact code 4650: suggested code "intubation." cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2024.The patient was stable prior to the procedure but had several comorbidities and was considered high risk.After the procedure, the patient experienced shortness of breath and oxygen and cpap were used at the bedside.The patient was admitted to the cardiovascular intensive care unit for observation.The patient continued to experience breathing issues and was intubated on (b)(6) 2024.Barostim therapy was turned off on (b)(6) 2024 until the patient became more stable.The patient was being diuresed, and an echocardiogram noted sever reduced function.An attempt to extubate the patient was made on (b)(6) 2024, but the extubation failed, and the patient remained intubated.It was noted the patient had pneumonia thought to be caused by intubation aspiration.Antibiotics were started.It was determined that the patient experienced a pulmonary edema, but the root cause was undetermined.As of (b)(6) 2024, the patient was still in the cvicu.It was noted that the patient was developmentally delayed and during a prior procedure unrelated to barostim, the patient also experienced similar breathing issues that resulted in hospitalization.Intubation was removed on (b)(6) 2024 at the request of the family, and the patient was placed on palliative care.The patient passed away on (b)(6) 2024.

Event Description

A barostim system was implanted on (b)(6) 2024.The patient was stable prior to the procedure but had several comorbidities and was considered high risk.After the procedure, the patient experienced shortness of breath and oxygen and cpap were used at the bedside.The patient was admitted to the cardiovascular intensive care unit for observation.The patient continued to experience breathing issues and was intubated on (b)(6) 2024.Barostim therapy was turned off on (b)(6) 2024 until the patient became more stable.The patient was being diuresed, and an echocardiogram noted severely reduced function.An attempt to extubate the patient was made on (b)(6) 2024, but the extubation failed, and the patient remained intubated.It was noted the patient had pneumonia thought to be caused by intubation aspiration.Antibiotics were started.It was determined that the patient experienced a pulmonary edema, but the root cause was undetermined.As of (b)(6) 2024, the patient was still in the cvicu.It was noted that the patient was developmentally delayed and during a prior procedure unrelated to barostim, the patient also experienced similar breathing issues that resulted in hospitalization.Intubation was removed on (b)(6) 2024 at the request of the family, and the patient was placed on palliative care.The patient passed away on (b)(6) 2024.In the opinion of the physician, anesthesia complications were the cause of the initial need to intubate, and the patient's comorbidities resulted in the patient's decompensation and eventual passing.

Manufacturer Narrative

Updated fields.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 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis 55445
• MDR Report Key: 18885037
• MDR Text Key: 337419354
• Report Number: 3007972010-2024-00007
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)250412
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2023
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 350 KG
• Patient Race: White