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

Model Number	2102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2022.The patient developed symptoms of an infection, including swelling at the neck incision, and was hospitalized on (b)(6) 2022.The patient was treated with iv antibiotics from (b)(6) 2022 through (b)(6) 2022.The patient was discharged on (b)(6) 2022 on oral antibiotics, and an explant was scheduled for (b)(6) 2022.The patient was re-admitted on (b)(6) 2022 in preparation for the explant on (b)(6) 2022.During the procedure, the pocket was washed out, and a culture taken.The barostim system was not explanted.The patient remained hospitalized on antibiotics.Culture results came back as methicillin-resistant staphylococcus aureus (mrsa), and a second procedure was performed on (b)(6) 2022 to explant the system.As of (b)(6) 2022, the patient remained hospitalized and on antibiotics.
Additional Manufacturer Narrative
The results of the investigation are inconclusive 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, and a supplemental report will be submitted when received.The device history record 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 as well as sterilization requirements.Cvrx id# (b)(4).
Additional Manufacturer Narrative
Cvrx id: (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2022.The patient developed symptoms of an infection, including swelling at the neck incision, and was hospitalized on (b)(6) 2022.The patient was treated with iv antibiotics from (b)(6) 2022 through (b)(6) 2022.The patient was discharged on (b)(6) 2022 on oral antibiotics, and an explant was scheduled for (b)(6) 2022.The patient was re-admitted on (b)(6) 2022 in preparation for the explant on (b)(6) 2022.During the procedure, the pocket was washed out, and a culture taken.The barostim system was not explanted.The patient remained hospitalized on antibiotics.Culture results came back as methicillin-resistant staphylococcus aureus (mrsa), and a procedure was performed on (b)(6) 2022 to explant the system, and the patient remained on oral antibiotics post explant.As of (b)(6) 2022, the patient had been released from the hospital, but the site declined to provide information on if the infection cleared.

• Brand Name: BAROSTIM NEO
• Common Device Name: 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: 14305602
• Report Number: 3007972010-2022-00006
• Device Sequence Number: 5376586
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)230617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/17/2023
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 137 KG
• Patient Race: White