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

Model Number 1036

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2023

Event Type  Injury  

Event Description

As of (b)(6) 2023, the physician reported that the lead impedance was in the high range.The impedance was previously 800, and increased to1200 and higher.The patient did not experience any adverse events related to the high impedance.As of (b)(6) 2023, the impedance was high again and x-rays were taken.The results showed that the lead appeared to be disconnecting from the ipg.There were no adverse events reported by the patient.On (b)(6) 2023, a pocket revision was performed.When the electrode was unscrewed from the device it was reported that the electrode was defective, likely indicating the terminal pin and/or seals were damaged due to the setscrews not being fully tightened or loosened.The ipg was removed and the device was left off until the patient decides how they want to proceed.

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)(4).

Event Description

On (b)(6) 2023, the physician reported that the lead impedance was in the high range.The impedance was previously 800, and increased to1200 and higher.The patient did not experience any adverse events related to the high impedance.As of 10-nov-23, the impedance was high again and x-rays were taken.The results showed that the lead appeared to be disconnecting from the ipg.There were no adverse events reported by the patient.On (b)(6) 2023, a pocket revision was performed.When the electrode was unscrewed from the device it was reported that the electrode was defective, likely indicating the terminal pin and/or seals were damaged due to the setscrews not being fully tightened or loosened.The ipg was explanted, and the patient was going to determine how they wanted to proceed.As of (b)(6) 2024 there was no update from the patient regarding receiving a new device.

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: 18389787
• MDR Text Key: 331292906
• Report Number: 3007972010-2023-00057
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• 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: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 70 KG
• Patient Race: White