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 Problem Speech Disorder (4415)

Event Date 12/09/2022

Event Type  Injury  

Event Description

A normal battery replacement occurred on (b)(6) 2022.The patient had requested that intratracheal narcotic (itn) anesthesia be used rather than local anesthesia.Following the procedure, the patient experienced aphasia and was transferred to a neurological center.It was noted that the patient had experienced both neurological issues and strokes in the past.An mri was performed, and no signs of stroke were found.The root cause of the aphasia was unable to be determined.As of (b)(6) 2022, the patient had no remaining signs of aphasia, and the patient was released home on (b)(6) 2022.

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 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).

• 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: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 16120639
• MDR Text Key: 306889316
• Report Number: 3007972010-2023-00002
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004005
• UDI-Public: (01)00859144004005(17)240428
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 2102
• Device Catalogue Number: 100054-201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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): Hospitalization
• Patient Sex: Male