MAUDE Adverse Event Report: CVRX, INC. BARSTIM NEO2; IMPLANTABLE PULSE GENERATOR

Model Number	2104
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2025 and last titrated from 3.8 to 6.2ma on (b)(6) 2026.Starting on (b)(6) 2026, the patient experienced a "flutter" near the ipg site without pain or discomfort.It was also noted that the ipg had almost flipped.Device interrogation occurred on (b)(6) 2026, impedance trends were stable, and barostim therapy was not changed.Chest and neck x-rays showed the csl overlying the ipg instead of the excess lead being located laterally to the ipg.The positioning of the lead was suggestive of device migration, and appropriate intervention was being assessed.In the opinion of the physician, while the root cause was unable to be conclusively determined, the patient's anatomy, particularly their heavier chest, and mobility may have contributed.A pocket revision occurred on (b)(6) 2026, and two sutures were still attached to the ipg and were required to be cut.The ipg was placed submuscularly with the excess csl placed above in the original pocket.There was no contact with the ipg and excess lead, and impedance remained stable throughout the procedure.As of 26-may-2026, the patient was doing well with no continuing "flutter" reported.
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 unable to be conclusively determined, the patient's anatomy, particularly their heavier chest, and mobility may have contributed.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.H6: health effect clinical code 4581: suggested code: general sensation cvrx id# (b)(4).

• Brand Name: BARSTIM NEO2
• 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: 25302314
• Report Number: 3007972010-2026-00063
• Device Sequence Number: 13073706
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)260806
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/06/2026
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• 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: 08/06/2024
• 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: 48 YR
• Patient Sex: Female
• Patient Race: Black Or African American