MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; CAROTID SINUS LEAD

Model Number 2102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hiccups (1899); Vomiting (2144); Syncope/Fainting (4411)

Event Date 04/30/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information received from the site, the hiccup-induced vomiting and syncope was procedurally related to the high bifurcation of the patient's anatomy.The opinion of the physician was that the event was not related to the device.The device history and sterilization records 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.(b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.Therapy was left activated at 125/1/40.On (b)(6) 2022 the patient experienced a syncopal episode due to hiccup induced vomiting.The patient was admitted to the hospital on (b)(6) 2022.No device intervention was performed, and the patient was managed with medications.The patient was fully recovered and discharged home on (b)(6) 2022.In the opinion of the physician, the hiccup-induced vomiting and syncope was procedurally related to the high bifurcation of the patient's anatomy and was not related to the device.

• Brand Name: BAROSTIM NEO
• Type of Device: CAROTID SINUS LEAD
• 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: 14705713
• MDR Text Key: 294904816
• Report Number: 3007972010-2022-00009
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)231006
• 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
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2023
• 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: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Race: Black Or African American