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 Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/19/2022

Event Type  Injury  

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 contributed to by the anesthesia protocol during the procedure.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.Health effect clinical code 4581: suggested codes are "volume depletion" and "elevated creatinine." cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.Shortly after, the patient experienced volume depletion with an elevated creatinine, along with blood pressure of 70/50.Medications were stopped, and a dobutamine drip was administered.A heart catheterization was performed on (b)(6) 2023.After the heart catheterization, the patient was stable, blood pressure had improved, and creatinine had decreased from 4.9 to 3.9.No additional adverse event was reported at the second follow-up.In the opinion of the physician, the anesthesia used with the procedure contributed to the event.The anesthesia protocol was sevoflurane at 1/2 mac, versed and either fentanyl or remifentanil.

• 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: 16292823
• MDR Text Key: 308735855
• Report Number: 3007972010-2023-00003
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)240311
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2024
• 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: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male