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 Problem Convulsion/Seizure (4406)

Event Date 01/31/2024

Event Type  Injury  

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 related to the anesthesia used during the procedure.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).

Event Description

A barostim system was implanted on (b)(6) 2024.Following surgery, the patient was mobile and recovering.Later that day, it was reported that the patient experienced seizures and was unresponsive.The patient was transferred to the intensive care unit.An mri was performed, and the barostim therapy was left activated at the post-implant, non-therapeutic level.Per the opinion of the physician, the seizures were caused by a reaction to the anesthesia.It was noted that the patient had experienced complications due to anesthesia in the past.As of the week of (b)(6) 2024, the patient had recovered normal function and had been discharged.

• Brand Name: BAROSTIM NEO2
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis 55445
• MDR Report Key: 18784186
• MDR Text Key: 336263703
• Report Number: 3007972010-2024-00004
• Device Sequence Number: 1
• Product Code: DSR
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2023
• 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): Other
• Patient Age: 53 YR
• Patient Sex: Male