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 Dizziness (2194); Implant Pain (4561)

Event Date 08/28/2023

Event Type  Injury  

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.(b)(4).

Event Description

A barostim system was implanted on (b)(6) 2023, and therapy was left at the sub-therapeutic level of 1ma.The patient was planned to be discharged after a 12 hour observation period, however, the patient was still inpatient on (b)(6) 2023.It was noted the patient had complained of surgical site pain, and oxycodone was administered.It was unknown why the patient was not given tylenol and discharged.The patient was still inpatient on (b)(6) 2023, and complained of pain.It was reported that oxycodone had been administered to the patient multiple times and the patient was somnolent.Pain medications were discontinued (b)(6) 2023 on the direction of the physician to discharge the patient.As of (b)(6) 2023, the patient was still inpatient and complaining of surgical site pain.Later that day, the patient reported to be dizzy and barostim therapy was turned off.It was noted that there were no notes in the patient's chart that they experienced pain or dizziness, but the patient stated they experienced pain starting at the pocket site going up to their neck.The managing physician was unable to determine the root cause of the dizziness.As of the evening of (b)(6) 2023, the patient stated the pain had subsided.The patient was discharged over the weekend of (b)(6) 2023.

• 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: 17797893
• MDR Text Key: 324018587
• Report Number: 3007972010-2023-00046
• 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
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Female