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

Model Number 2102

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Thrombocytopenia (4431)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive at this time since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Additional information has been requested from the facility.If the additional information is received from the site, a final report will be submitted when the information is received.The device history record and sterilization records for the reported ipg and csl have 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.(b)(4).

Event Description

An ipg replacement and relocation was performed on (b)(6) 2021.On (b)(6) 2021, a pet scan showed an infection along the lead and reaching 3-4 cm above the ipg.No other signs of infection was observed at other locations of the system.On (b)(6) 2021, the patient developed a hematoma near the new ipg.A small procedure was performed to drain the hematoma.The patient was discharged during the weekend of (b)(6) 2021 with a 14-day course of linexolide and ongoing doxycycline.It was noted that the patient had a "slow growing germ." a follow-up appointment was performed on (b)(6) 2021, and the antibiotics were continued, and a pet scan was planned for (b)(6) 2021.On the weekend of (b)(6) 2021, the patient experienced thrombocytopenia due to the antibiotics, the antiobiotherapy was adjusted, and the platelet count increased.It was expected the antibiotics could be stopped on (b)(6) 2021, and an explant would not be required.This event was a continuation of a previous event, where the ipg was located outside of the pocket.At that time it was recommended by cvrx to explant the lead due to the risk of infection; however, the doctors determined that it wasn't necessary.

Manufacturer Narrative

This event was a continuation of (b)(4), where the ipg was located outside of the pocket.At that time it was recommended by cvrx to explant the lead due to the risk of infection; however, the doctors determined that it wasn't necessary.The devices remained implanted, so no device was returned for analysis.Based on the information received, it is likely that the movement of the lead contributed to the infection and the implant procedure contributed to the hematoma that formed at the new ipg site.The device history records for the ipg and csl serial numbers have 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

An ipg replacement and relocation was performed on (b)(6) 2021, and the existing lead was tunneled to the new ipg location.At that time, it was recommended by cvrx to explant the lead due to the risk of infection; however, the doctors determined that it wasn't necessary.On (b)96) 2021, a pet scan showed a suspected infection along the lead and reaching 3-4 cm above the new ipg and infection along the tunneled lead track from the right to left side.No other signs of infection was observed at other locations of the system or in the neck.On (b)(6) 2021, the patient developed a hematoma near the new ipg.A small procedure was performed to drain the hematoma.The patient was discharged during the weekend of (b)(6) 2021 with a 14-day course of linexolide and ongoing doxycycline.It was noted that a "slow growing germ" was suspected.A follow-up appointment was performed on (b)(6) 2021, and the antibiotics were continued, and a pet scan was planned for (b)(6) 2021.On the weekend of (b)(6) 2021, the patient experienced thrombocytopenia due to the antibiotics, the antiobiotherapy was adjusted, and the platelet count increased.It was expected the antibiotics could be stopped on (b)(6) 2021, and an explant would not be required.As of (b)(6) 2022, nothing was observed on follow-up pet scans or ultrasounds, there were no signs of infection, and antibiotics had been discontinued.The patient will continue to be monitored to ensure the infection does not recur.It was noted that the patient's scars were healing well.

• 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: 13011397
• MDR Text Key: 288058628
• Report Number: 3007972010-2021-00004
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004005
• UDI-Public: (01)00859144004005(17)230504
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: 2102
• Device Catalogue Number: 100054-201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White