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	Dyspnea (1816); Discomfort (2330); Twiddlers Syndrome (4563); Swelling/ Edema (4577)
Date of Event	03/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was suspected to be twiddlers syndrome due to twisting and turning of the battery/generator in its pocket.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)(6).
Event or Problem Description
A barostim system was implanted on (b)(6) 2025.On (b)(6) 2026, the patient presented to the emergency room with shortness of breath, swelling and abdominal pain and an x-ray was done routinely and showed the ipg projecting over their right upper chest, extending into the right neck, with several twists and turns along the path of the lead.Around 30-mar-2026, the patient experienced tightness in their neck when they turn their head to the right and on (b)(6) 2026, they had a virtual follow up with their physician.It was suspected that the root cause was twiddlers syndrome due to twisting and turning of the battery/generator in its pocket.An x ray was done, revealing a twist in the lead.It was noted that the lead did not appear fractured and they were unsure if the device was working.The patient was seen for a follow up on (b)(6) 2026 and their lead impedance was at 130.On (b)(6) 2026, a successful lead revision was done.The fractured lead was cut, and a new lead was placed to the left carotid.Per the opinion of the physician, it was suspected that that the sob may have been caused by barostim not delivering the therapy appropriately, and as of (b)(6) 2026, the patient reported that they were doing well and not experiencing sob.

• 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: 25306882
• Report Number: 3007972010-2026-00066
• Device Sequence Number: 21211714
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)270306
• 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: 2025
• Device Explanted Year: 2026
• 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): 05/27/2026

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: 04/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: 24 YR
• Patient Sex: Female
• Patient Weight: 143 KG
• Patient Race: Black Or African American