MAUDE Adverse Event Report: CVRX, INC BAROSTIM NEO2; CAROTID SINUS LEAD

Model Number	1036
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Twiddlers Syndrome (4563)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Nebraska low impedance- a barostim system was implanted on (b)(6) 2025.Around (b)(6) 2026, the patient experienced an intermittent gurgling sensation at the ipg location.The patient denied manipulating the device or experiencing any trauma that might have impacted the device.They reported that when sleeping at night, the device "poked out".While reviewing the impedance trend, it was noted that there was a steep dip in impedance that correlated with the day the patient began to experience symptoms.The gurgling sensation and low impedance of 330 was replicable while the patient was moving around.When the patient was seated the impedance went back to 803.The patient's therapy was reduced to 5ma and xray was ordered and revealed twists in the lead.A lead and pocket revision occurred on (b)(6) 2026.A new lead was implanted, and the device was secured in the pocket.As of (b)(6) 2026, the patient's symptoms were resolved and the impedance was normal.
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, the root cause of the event was the device flipping over multiple times until the lead was damaged.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.Id# (b)(4).

• Brand Name: BAROSTIM NEO2
• Common Device Name: CAROTID SINUS LEAD
• Manufacturer (Section D): CVRX, INC; 9201west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer (Section G): CVRX, INC; 9201west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: vincent mbibi ; 9201west broadway avenue; suite 650; minneapolis, MN 55445 ; 7634162856
• MDR Report Key: 25300149
• Report Number: 3007972010-2026-00064
• Device Sequence Number: 21187846
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)270108
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 07/07/2026

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 Model Number: 1036
• Device Catalogue Number: 100063-212
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Race: White