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 Code	Medical device site infection (4845)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ipg and proximal portion of the csl were received at cvrx for analysis.Scratches were visually observed on the ipg consistent with explant damage.Damage consistent with explant was observed on the proximal portion of the csl.No damage was seen that would be associated with an infection.At the conclusion of device analysis, the reported event was unable to be confirmed.Per the report of the physician, the barostim device shared a pocket with an infected pacemaker system.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.Bioburden, pyrogen, lal, and cleanroom cae testing results were below control limits for the quarter the ipg was manufactured.The device met material, assembly, and quality control requirements.Cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2022 and had pacemaker replacement on (b)(6) 2025.As of (b)(6) 2025, the patient's pacemaker system was infected.It was noted the barostim device was also possibly infected as two right-sided pacing leads shared the ipg pocket.The patient had the ipg and csl explanted on (b)(6) 2025.As of (b)(6) 2026, the patient had had an icd implanted since the explant, had their antibiotics discontinued, and were doing well.

• Brand Name: BAROSTIM NEO
• 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: 24396888
• Report Number: 3007972010-2026-00019
• Device Sequence Number: 18222306
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)240815
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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 Expiration Date: 08/15/2024
• Device Model Number: 2102
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Race: White