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

Model Number 2102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.The cause of the infection was unable to be undetermined.The device history and sterilization records 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 cvrx barostim system was implanted on (b)(6) 2022.On (b)(6) 2022, pain and symptoms of an infection occurred at the neck location.The area was swollen, the incision had reopened, and liquid was coming out of the reopened incision.The patient was hospitalized and was treated with iv antibiotics.The patient did not experience a fever, and the cause of the infection was unknown.The infection site was swabbed, and the analysis was returned as staphylococcus.On (b)(6) 2022, iv antibiotics were stopped, and the patient was discharged.The patient and the infection were improved.

• 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: 14945383
• MDR Text Key: 295419397
• Report Number: 3007972010-2022-00010
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004265
• UDI-Public: (01)00859144004265(17)230610
• 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
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/10/2023
• Device Model Number: 2102
• Device Catalogue Number: 100063-211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Race: White