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

Model Number 1036

Device Problems Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

Patient Problem Implant Pain (4561)

Event Date 11/24/2022

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 twiddling of the device by the patient.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).

Event Description

A barostim system was implanted on (b)(6) 2022.During a routine follow-up on (b)(6) 2022, the device did not pass compliance and had low impedance.The patient reported experiencing strong pain in the ipg pocket several times since the start of therapy.X-rays were performed, and it was observed that the lead showed evidence of being twiddled, and the ipg had changed direction.It was noted that the ipg had not been sutured during the implant procedure.On (b)(6) 2022, a revision occurred.The pocket was opened, and the csl was untwisted and straightened.Thereafter, the impedance of the csl was in range and steady, and the system passed compliance.The ipg was sutured into the pocket.The patient was doing well following the procedure.

Manufacturer Narrative

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: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 16018494
• MDR Text Key: 305873249
• Report Number: 3007972010-2022-00022
• Device Sequence Number: 1
• Product Code: DSR
• 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,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2024
• Device Model Number: 1036
• Device Catalogue Number: 100063-211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 78 KG