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

Model Number	2102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Skin Inflammation/ Irritation (4545)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• MDR Report Key: 12177914
• Report Number: 3007972010-2021-00002
• Device Sequence Number: 2807584
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)220618
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR
• Patient Weight: 75