MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; IMPLANTABLE PULSE GENERATOR

Model Number 2102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/12/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6)2023, the patient was admitted to the hospital with an infection.It was noted that a right heart catheterization (rhc) was performed via access by the right internal jugular (rij), and an infection occurred.The barostim system was explanted on (b)(6) 2023, and vancomycin was administered.The patient's next appointment was scheduled for (b)(6)2023.

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 a right heart catheterization procedure.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.Cvrx id#(b)(4).

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient was admitted to the hospital with an infection.It was noted that a right heart catheterization (rhc) was performed via access by the right internal jugular (rij), and an infection occurred.The barostim system was explanted on (b)(6) 2023, and vancomycin was administered.As of on (b)(6) 2023, the infection had cleared, and the patient was ready to be reimplanted.

Manufacturer Narrative

Analysis in progress.Cvrx id# (b)(4).

Manufacturer Narrative

Updated fields: b4, g6, h2, h3, h10 analysis in progress.Cvrx id (b)(4).

Manufacturer Narrative

The reported ipg and csl were received at cvrx for analysis.Visual inspection revealed no issues.Interrogation of the ipg showed no exceptions or error.Based on the information received, per the opinion of the physician, the root cause of the event was a right heart catheterization procedure.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.(b)(4).

• Brand Name: BAROSTIM NEO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 17266796
• MDR Text Key: 318554938
• Report Number: 3007972010-2023-00029
• Device Sequence Number: 1
• Product Code: DSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Race: Black Or African American