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

Model Number 1036

Device Problem Material Twisted/Bent (2981)

Patient Problems Implant Pain (4561); Twiddlers Syndrome (4563)

Event Date 02/18/2024

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 the patient twiddling their device.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) 2023.On (b)(6) 2023, the patient presented at the emergency department with pain at both the neck and chest implant sites and was admitted.An x-ray showed the lead was twisted, and the patient was reported to have twiddled their device.It was noted that the ipg had originally been sutured with two sutures per the instructions for use.Lead impedance decreased significantly approximately on (b)(6) 2024.The patient experienced extraneous stimulation, and therapy was decreased on (b)(6) 2024 which resolved the extraneous stimulation.It was not yet determined if the lead was going to be revised.

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6) 2024, the patient presented at the emergency department with pain at both the neck and chest implant sites and was admitted.An x-ray showed the lead was twisted, and the patient was reported to have twiddled their device.It was noted that the ipg had originally been sutured with two sutures per the instructions for use.Lead impedance decreased significantly approximately on (b)(6) 2024.The patient experienced extraneous stimulation, and therapy was decreased on (b)(6) 2024 which resolved the extraneous stimulation.The system was replaced on (b)(6) 2024, and the patient was discharged on (b)(6) 2024.The patient only experienced normal post-op pain without the pain they were experiencing prior to the replacement.

Manufacturer Narrative

Cvrx id# (b)(6).

• Brand Name: BAROSTIM NEO
• Type of Device: CAROTID SINUS LEAD
• 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: 18920312
• MDR Text Key: 337849852
• Report Number: 3007972010-2024-00008
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)250718
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: Black Or African American