MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO2; IMPLANTABLE PULSE GENERATOR

Model Number 2104

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

Patient Problems Bacterial Infection (1735); Low Blood Pressure/ Hypotension (1914); Sepsis (2067)

Event Date 11/22/2023

Event Type  Injury  

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.Mdr initially submitted under 3007972010-2023-00057 which already had an initial report submitted.Resubmitting under 3007972010-2023-00058.Cvrx id#(b)(4).

Event Description

It was reported that the patient was admitted and had their device explanted on (b)(6) 2023 due to a systemic bacteremia.The root cause is currently unknown, but it was suspected that implants performed in rapid timeframe could have contributed.The patient was discharged from the hospital.

Manufacturer Narrative

While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the bacteremia was an infected cardiac device.Cvrx id# (b)(6).

Event Description

On (b)(6) 2023, it was reported that the patient was admitted on (b)(6) 2023 with drainage from their implantable cardioverter defibrillator pocket and had their implantable cardioverter defibrillator and barostim devices explanted on (b)(6) 2023 due to a systemic bacteremia.The patient suffered septic shock due to abscess of chest and bacteremia.The patient also experienced persistent hypotension which required vasopressors.The culture result was positive for klebsiella and pseudomonas aeruginosa and the patient received antibiotics intravenously.It was originally suspected that implants performed in rapid timeframe could have contributed to the event.However, per the opinion of the physician, the root cause of the event was an infected cardiac device.The patient was feeling well and was discharged from the hospital on (b)(6) 2023 with a peripherally inserted central catheter line antibiotic that was to be continued until (b)(6) 2023.It was confirmed that the picc line antibiotic treatment was completed and removed and the infection was resolved.

Manufacturer Narrative

The investigation conclusion was changed from cause not established to a more appropriate code of cause traced to another device.Cvrx id# (b)(4).

• Brand Name: BAROSTIM NEO2
• Type of Device: IMPLANTABLE PULSE GENERATOR
• 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: 18686399
• MDR Text Key: 335138777
• Report Number: 3007972010-2023-00058
• Device Sequence Number: 1
• Product Code: DSR
• 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,Followup,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2022
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 144 KG
• Patient Ethnicity: Non Hispanic