MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO2; CAROTID SINUS LEAD

Model Number 1036

Device Problems Fracture (1260); Low impedance (2285); Material Twisted/Bent (2981)

Patient Problem Neck Pain (2433)

Event Date 08/27/2022

Event Type  Injury  

Manufacturer Narrative

A portion of the csl was received at cvrx for analysis.The returned csl did not include the electrode section.The csl was tightly tangled, and the inner coil beyond the suture tab was stretched, broken, and exposed with no insulation.The lead was unable to be functionally tested as the electrode was not returned.No manufacturing defects were observed.The root cause of the event was determined to be related to the patient twiddling their system.The device history record and sterilization record for these device serial numbers have been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The devices met material, assembly, and quality control requirements.Cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.On (b)(6) 2022, the patient had their second follow-up appointment, the lead impedance was low, and the compliance failed.Additional impedance tests were performed, but the issue persisted.The lead impedance trend showed that the impedance dropped low and remained low on (b)(6) 2022 in the evening.The patient reported experiencing a sharp neck pain around that time, which was followed by intermittent ipg movement.A chest and neck x-ray was performed, the lead was balled up near the ipg, and the ipg had flipped.A revision was performed on (b)(6) 2022.It was found that the ipg sutures were still in place on the ipg but had pulled out of the tissue.The device had been twiddled, and there were many tension loops in the csl.The csl had fractured.The csl was replaced, and the ipg was reimplanted with the sutures being placed deeper in the tissue.The patient was doing well following the procedure.

• Brand Name: BAROSTIM NEO2
• 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: 15770563
• MDR Text Key: 303410498
• Report Number: 3007972010-2022-00020
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)240308
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2024
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White