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

Model Number 1036

Device Problem Unintended Electrical Shock (4018)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 06/01/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6) 2023.During a normal follow-up on (b)(6) 2023, the patient reported experiencing extraneous stimulation during "very active" shoulder movements such as fishing or digging.It was noted the stimulation dissipated when a finger was placed on the incision site.The stimulation was unable to be duplicated during the follow-up, and therapy was decreased.During a follow-up on (b)(6) 2023, it was reported the patient continued to experience extraneous stimulation.Additional therapy changes were performed, and the patient was not experiencing stimulation at the end of the follow-up.Four days later, the extraneous stimulation recurred.The patient notes that when they push on the neck area near the incision, the sensations resolve.An x-ray was performed, and, per the physician, was unremarkable.A lead replacement occurred on (b)(6) 2023 where the existing lead was capped and a new lead placed on the opposite left side.The patient was discharged on (b)(6) 2023 and as of 19-oct-2023, the patient was doing well and the incision site looked good.

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 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)(6).

Manufacturer Narrative

Updated fields: b4, g3, g6, h2 the date of the initial report, 3007972010-2023-00052, was inadvertently entered as 10/20/2023.The initial report was submitted on 10/26/2023.Cvrx id# (b)(4).

• 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: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445 ; 6125989984
• MDR Report Key: 18016373
• MDR Text Key: 326677274
• Report Number: 3007972010-2023-00052
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)240825
• 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,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male