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); Post Operative Wound Infection (2446); Swelling/ Edema (4577)

Event Date 12/14/2023

Event Type  Injury  

Event Description

The patient was implanted on (b)(6) 2023.On (b)(6) 2023, the patient was seen for a routine follow -up and the incision site of the pocket appeared to be swollen and an ultrasound was performed which revealed fluid in the site.The incision site was drained on (b)(6) 2023 and the fluid in the site was seroma.The result form the cultures taken was mrsa positive.A wound vacuum was placed.The patient remained hospitalized following the pocket irrigation and was undergoing inpatient diuresis.Per the opinion of the physician, the patient was noncompliant and did not take diuretics following the barostim procedure as prescribed.This led to fluid accumulation and seroma.The patient received intravenous antibiotics.On (b)(6) 2023, the infection resolved, and the patient was discharged.

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 due to the patient being noncompliant and not taking diuretics following the barostim procedure as prescribed.This led to fluid accumulation and seroma.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

(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: 18530240
• MDR Text Key: 333075149
• Report Number: 3007972010-2023-00062
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)240330
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2024
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White