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 Problems Myocardial Infarction (1969); Skin Inflammation/ Irritation (4545)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

Interviews with the surgeon and cardiologist confirm that the patient's underlying cardiac condition and history along with the anesthesia regimen likely resulted in the nstemi and mi is an identified inherent risk associated with the use of the system.These interviews also confirmed that a desire to restart anticoagulant therapy soon after the implant procedure resulted in the prolonged hospitalization to monitor the swelling in the patient's neck prior to release.Both concerns were reported to have completely resolved.

Event Description

Patient was implanted on (b)(6) 2021 with the barostim neo system.On or about (b)(6) 2021 the patient experienced a non-st segment elevation myocardial infarction (nstemi) which was managed with nitroglycerin and did not require catheterization.The surgeon and cardiologist attributed this to the anesthesia regimen for the implant procedure.The patient was reported to have an extensive cardiac history including past nstemi events.Patient was hospitalized until (b)(6) 2021 but not due to the nstemi.This was reportedly due to additional swelling at the neck incision site related to restarting of anticoagulation therapy soon after the procedure.All events were reportedly addressed and felt to resolve quickly with medical management on the floor and did not require additional invasive procedures.Cvrx was not made aware of this event until (b)(6) 2021.

• 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: al crouse ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445 ; 7634167457
• MDR Report Key: 12177914
• MDR Text Key: 261908451
• Report Number: 3007972010-2021-00002
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)220618
• 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
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• 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: 06/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 75