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); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/09/2023

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.Cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient reported experiencing worsening hf symptoms, low blood pressure, and dizziness since their last titration on (b)(6) 2023.The patient's blood pressure on (b)(6) 2023 was 95/59.During device programming, the patient became dizzy and experienced low blood pressure of approximately 80/40 to 75/40.It was noted the patient's heartbeat may have been irregular, and the barostim device was turned off for an ekg.The ekg showed frequent premature ventricular contractions.While awaiting transport to the emergency department, the patient's blood pressure improved to 100+/70+, and the premature ventricular contractions were no longer occurring.The patient was admitted to the hospital from (b)(6) to (b)(6).During hospitalization, it was found that there was a 60-70% blockage in a previously stented heart vessel, and the patient had low potassium.Medications were adjusted and a later heart intervention was planned but not scheduled.It was noted the patient's icd was not checked during the hospitalization.The patient noted feeling improved when potassium was administered in the hospital.Barostim therapy was restarted on (b)(6) 2023.The physician was unable to determine if barostim therapy contributed to the event.A follow-up appointment was scheduled for (b)(6) 2023.

• Brand Name: BAROSTIM NEO
• 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: 17735751
• MDR Text Key: 323271008
• Report Number: 3007972010-2023-00044
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)230720
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• 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: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Race: White