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

Model Number 1036

Device Problems Degraded (1153); Low impedance (2285)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 07/11/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient presented to the emergency department experiencing shocking sensations near the neck incision.They stated they had experienced the shocking sensations a few times in the past, but it had occurred on and off all day on (b)(6) 2023.System interrogation showed a low impedance of 164 ohms, and the sensation was recreated during each impedance check or change to therapy settings.The root cause of the low impedance was unable to be determined, and the patient did not recall any falls, accidents, physical or massage therapy, or chiropractic visits.Therapy was disabled, and the patient was released without admittance.A csl replacement occurred on (b)(6) 2023.It was observed that the insulation was stripped from approximately 1/3 of the csl.The root cause of the lead insulation damage was unable to be determined.The patient reported they did not twiddle the device.As of (b)(6) 2023, it was reported the patient was no longer experiencing any adverse event.

Manufacturer Narrative

The reported csl was received at cvrx for analysis.The csl was received in three pieces.Two to three nicks were observed, which appeared to be from a blade, which may have occurred during explant.The distal section returned appeared to have been cleanly cut, such as by a blade, and did not have the appearance of a tear from twiddling or other manual manipulation.The distal section internal coil was stretched beyond the silicone tubing, with the silicone tubing being the length expected of a csl, indicating no part of the silicone tubing was missing.Functional testing of returned device is not possible due to the lead being returned in multiple pieces.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).

• 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: 17623374
• MDR Text Key: 321944044
• Report Number: 3007972010-2023-00040
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)250113
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Race: Black Or African American