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 Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 10/27/2023

Event Type  Injury  

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)(4).

Event Description

A barostim system was implanted on (b)(6) 2023.The patient reported that on 22-oct-2023, an infection began to occur and they experienced pain in the area of the pocket.Pocket drainage and a scope by the physician occurred the week of 23-oct- 2023, and the patient was put on oral antibiotics which was discontinued on 28-oct-2023.The ipg was explanted on (b)(6) 2023 and the ipg was sent to pathology.In the opinion of the physician, it was unsure if the cause of the infection was ethibond or why the infection began weeks after the implant.More information is to be provided as received.

Manufacturer Narrative

The reported ipg and csl were received at cvrx for analysis.There were minor gouges and scratches observed on the ipg header and case which is not unusual for an explanted ipg.The cause of the scratches is undetermined but is likely the result of explanting and handling of the ipg.Light stains were observed which is not unusual for an explanted ipg as it must go through decontamination which uses chemical solutions.The ipg functioned as expected during analysis.The cause of the reported event could not be conclusively determined.Cvrx id# (b)(4).

Manufacturer Narrative

Cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2023.The patient reported that on (b)(6) 2023, an infection began to occur and they experienced pain in the area of the pocket.Pocket drainage and a scope by the physician occurred the week of (b)(6) 2023, and the patient was put on oral antibiotics which was discontinued on (b)(6) 2023.The ipg was explanted on (b)(6) 2023 and the ipg was sent to pathology.In the opinion of the physician, it was unsure if the cause of the infection was ethibond or why the infection began weeks after the implant.More information is to be provided as received.As of (b)(6) 2024, the patient had recovered and a new system was implanted.

• 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: 18202380
• MDR Text Key: 328891999
• Report Number: 3007972010-2023-00054
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)250104
• 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
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2023
• 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: 02/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White