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 Code	Cyst(s) (1800)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2024.On (b)(6) 2024, the patient was seen for what they thought was a pocket of pus.It was determined that the patient had a cyst and decision was made to remove it.The procedure was scheduled for on (b)(6) 2024.
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) 2024.On (b)(6) 2024, the patient was seen for what they thought was a pocket of pus.It was determined that the patient had a cyst and decision was made to remove it.The procedure was scheduled for (b)(6) 2024.On (b)(6) 2024, the patient was seen for a follow-up.The patient was doing great and presented with zero complaints.
Additional Manufacturer Narrative
Cvrx id# (b)(4).
Additional Manufacturer Narrative
Cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6)2024.On (b)(6)2024, the patient was seen for what they thought was a pocket of pus.It was determined that the patient had a cyst and on (b)(6)2024, a procedure was performed to remove it.Per the opinion of the physician, there was a small seroma and the fluid was evacuated.The patient received intravenous antibiotics pre-operation and the pocket was irrigated.The patient was stable and was discharged home on the same day.On (b)(6)2024, the patient was seen for a follow-up.The patient was doing great and presented with zero complaints.

• Brand Name: BAROSTIM NEO
• Common Device Name: 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: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 20534308
• Report Number: 3007972010-2024-00064
• Device Sequence Number: 8247760
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)240816
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2025

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: Lay User/Patient
• Device Expiration Date: 08/16/2024
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 02/24/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/16/2024; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2022
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White