MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO2; LMPLANTABLE PULSE GENERATOR

Model Number	2104
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577); Medical device site infection (4845)
Date of Event	02/21/2026
Type of Reportable Event	Serious Injury
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 these device serial numbers have been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.Bioburden, pyrogen, lal, and cleanroom cae testing results were below control limits for the quarter the ipg/csl was manufactured.The device met material, assembly, and quality control requirements.Csl device information: (b)(4) manufacture date: 2024-11-05 part number: 100063-212.Cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2025, and two sutures were used in fascia to anchor the ipg.The patient began experiencing tenderness and swelling near the ipg pocket on (b)(6) 2026.The patient visited the emergency room on (b)(6) 2026 and was told everything looked fine.It was noted no vascular or heart failure physicians or cvrx was contacted.The patient was admitted to the hospital on (b)(6) 2026 for a device/implant complication.Imaging was obtained, and it appeared the slack in the csl lead was no longer present.A procedure was performed on (b)(6) 2026.It was noted that the original ipg sutures were no longer attached, and, in the opinion of the physician, the stress caused the strain relief tab to disconnect as well.In the opinion of the physician, the patient either manipulated the ipg or the suture knots came loose.A pocket washout, ipg replacement and placement in antibacterial pouch, and lead revision to recreate the strain loop occurred.Cultures showed methicillin-resistant staphylococcus aureus (mrsa) present.The patient was discharged on (b)(6) 2026, and the pain and swelling had resolved at discharge.The patient was to receive iv antibiotics for six weeks, and oral antibiotics for an additional six months.
Event or Problem Description
A barostim system was implanted on (b)(6) 2025, and two sutures were used in fascia to anchor the ipg.The patient began experiencing tenderness and swelling near the ipg pocket on (b)(6) 2026.The patient visited the emergency room on (b)(6) 2026 and was told everything looked fine.It was noted no vascular or heart failure physicians or cvrx was contacted.The patient was admitted to the hospital on (b)(6) 2026 for a device/implant complication.Imaging was obtained, and it appeared the slack in the csl lead was no longer present.A procedure was performed on (b)(6) 2026.It was noted that the original ipg sutures were no longer attached, and, in the opinion of the physician, the stress caused the strain relief tab to disconnect as well.In the opinion of the physician, the patient either manipulated the ipg or the suture knots came loose.A pocket washout, ipg replacement and placement in antibacterial pouch, and lead revision to recreate the strain loop occurred.Cultures showed methicillin-resistant staphylococcus aureus (mrsa) present.The patient was discharged on (b)(6) 2026, and the pain and swelling had resolved at discharge.The patient was to receive iv antibiotics for six weeks, and oral antibiotics for an additional six months.As of (b)(6) 2026, the patient was doing well with no explant or other intervention beyond antibiotics planned.A follow-up was planned for (b)(6) 2026.
Event or Problem Description
A barostim system was implanted on (b)(6) 2025, and two sutures were used in fascia to anchor the ipg.The patient began experiencing tenderness and swelling near the ipg pocket on (b)(6) 2026.The patient visited the emergency room on (b)(6) 2026 and was told everything looked fine.It was noted no vascular or heart failure physicians or cvrx was contacted.The patient was admitted to the hospital on (b)(6) 2026 for a device/implant complication.Imaging was obtained, and it appeared the slack in the csl lead was no longer present.A procedure was performed on (b)(6) 2026.It was noted that the original ipg sutures were no longer attached, and, in the opinion of the physician, the stress caused the strain relief tab to disconnect as well.In the opinion of the physician, the patient either manipulated the ipg or the suture knots came loose.A pocket washout, ipg replacement and placement in antibacterial pouch, and lead revision to recreate the strain loop occurred.Cultures showed methicillin-resistant staphylococcus aureus (mrsa) present.The patient was discharged on (b)(6) 2026, and the pain and swelling had resolved at discharge.The patient was to receive iv antibiotics for six weeks, and oral antibiotics for an additional six months.As of (b)(6) 2026, the patient was doing well with no explant or other intervention beyond antibiotics planned.As of the week of (b)(6) 2026, the patient had completed their 6-week course of iv antibiotics, was doing well, and no additional intervention beyond an additional six months of oral antibiotics was planned.
Additional Manufacturer Narrative
Updated field: b4, b5, g3, g6, h2, h11.Cvrx id# (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h11.(b)(4).

• Brand Name: BAROSTIM NEO2
• Common Device Name: LMPLANTABLE 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: 24718425
• Report Number: 3007972010-2026-00033
• Device Sequence Number: 12292592
• Product Code: DSR
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2026

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: 02/02/2026
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 05/18/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/06/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 211 LB
• Patient Race: White