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

Model Number 2104

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

Patient Problems Seroma (2069); Swelling/ Edema (4577)

Event Date 06/05/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(4) 2023.On (b)(4) 2023, the patient experienced swelling and fluid build-up at the ipg pocket location.A replacement procedure occurred on (b)(4) 2023 where the ipg was explanted, and a new ipg placed.In the opinion of the physician, a possible seroma contributed to the pocket complication.Samples were sent to pathology for further analysis, and the patient was placed on antibiotics.

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 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)(6).

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient experienced swelling and fluid build-up at the ipg pocket location.The patient was admitted to the hospital on (b)(6) 2023, and iv antibiotics were administered.A replacement procedure occurred on (b)(6) 2023 where the ipg was explanted, and a new ipg placed.In the opinion of the physician, a seroma occurred that had been caused by the initial implant procedure.Samples were sent to pathology for further analysis, and all cultures were negative.The patient was discharged home on (b)(6) 2023.The patient recovered with no complications, and their wound was healing.

Manufacturer Narrative

Cvrx id#: (b)(4).

• Brand Name: BAROSTIM NEO2
• 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: 17248513
• MDR Text Key: 318302711
• Report Number: 3007972010-2023-00028
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)240920
• 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
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White