MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; IMPLANTABLE PULSE GENERATOR

Model Number	2102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Heart Failure/Congestive Heart Failure (4446); Hypokalemia (4825)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3007972010-2023-00044
• Device Sequence Number: 6551269
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)230720
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Race: White