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 Problem Post Operative Wound Infection (2446)

Event Date 06/06/2023

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.On (b)(6) 2023, the patient experienced a pocket infection including swelling and leakage from the pocket incision.The barostim system was explanted on (b)(6) 2023, and oral antibiotics were administered.

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient experienced a pocket infection including swelling and leakage from the pocket incision.The barostim system was explanted on (b)(6) 2023, and oral antibiotics were administered.As of on (b)(6) 2023, the infection was reported to have cleared, as the patient was scheduled for reimplantation, and the patient was reimplanted on (b)(6) 2023.

Manufacturer Narrative

The reported ipg and csl were received at cvrx for analysis.The lead was damaged during explant and received in two sections, but no additional damage was observed.There were visible minor scratches on the ipg which could have occurred during the removal.The ipg functioned as expected during analysis testing.No abnormalities were found during 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 number: (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: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 17218356
• MDR Text Key: 318038539
• Report Number: 3007972010-2023-00027
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)240209
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2024
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Race: White