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	Undesired Nerve Stimulation (1980); Discomfort (2330)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2022.In (b)(6) 2023, the patient experienced coughing fits due to a viral infection as well as tightness in their throat/a foreign body sensation when they bent over and pressure around the site of the lead.After a more violent coughing fit, the patient was worried the lead had dislodged.A ct scan showed the lead as expected.On approximately (b)(6) 2023, the coughing fits subsided, but the throat tightness remained present.It was noted that barostim therapy was increased over this time.On (b)(6) 2023, the therapy amplitude was reduced from 7ma to 3ma.The throat tightness subsided.The patient stated they felt much better but was not satisfied with the response they received from their physician and was advised to seek a second opinion.The second physician suggested that based on the existing ct scan, the strain relief loop was too big and may be pressing on a pharyngeal nerve.The patient returned to their original physician with the information and their therapy was turned off.While the therapy was off, the patient experienced increased hf symptoms, including fluid retention.The foreign body sensation was not resolved but the patient reported feeling somewhat better.The original physician was not convinced that the strain relief loop/nerve interaction was correct but there was consideration to if the patient had an undiagnosed connective tissue/elastic skin disorder.As of (b)(6) 2024, barostim therapy was restarted at a low setting, and the sensations were reported to be resolved.On (b)(6) 2024, the patient was seen by their physician and reported that the device was bothering their neck area and causing a choking sensation.It was noted that the patient wanted their device turned off.The patient met with a ct surgeon who was unfamiliar with barostim but was willing to remove the device.They wanted to have the device turned off for three months prior to surgery.On (b)(6) 2024, the patient's therapy was turned off.On (b)(6) 2025, the patient's device was explanted.Per the opinion of the physician, since the explant, the patient's neck issues improved but was not completely resolved.It was noted that their hf symptoms significantly worsened, granted barostim was off for some time before explant.
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).

• 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: 21986765
• Report Number: 3007972010-2025-00039
• Device Sequence Number: 18220672
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)231006(2102004319)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 05/08/2025

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: 10/06/2023
• 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: 04/10/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2021
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female