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

Model Number 1010R

Device Problem Expulsion (2933)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 01/17/2023

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.Cvrx id#: (b)(4).

Event Description

On (b)(6) 2023, the patient reported that the lead was exposed, and new drainage had been present at the pocket incision for approximately one week.A revision procedure occurred on (b)(6) 2023.The pocket was not infected and mostly healed.The lead was protruding from the patient, and discharge was present at that location.Both leads were cut above the signs of infection, and the cut lead portions were removed.The wounds were irrigated, and wound vac was applied, and the patient was prescribed oral antibiotics for two weeks.A culture was taken, but results were not shared.

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

On (b)(6) 2023, the patient reported that the lead was exposed, and new drainage had been present at the pocket incision for approximately one week.A revision procedure occurred on (b)(6) 2023.The pocket was not infected and mostly healed.The lead was protruding from the patient, and discharge was present at that location.Both leads were cut above the signs of infection, and the cut lead portions were removed.The wounds were irrigated, and wound vac was applied, and the patient was prescribed oral antibiotics for two weeks.As of on (b)(6) 2023, the patient was healing well, but the wound vac was still in place.The opinion of the healthcare professional was that the home nurse was applying too much pressure on the gauze as the wound is still deep.The home nurse was subsequently instructed to not apply pressure to the wound and gauze.Prior cultures taken had multiple gram negative and positive methicillin-susceptible staph organisms.On (b)(6) 2023, the wound vac was discontinued, and hydrogel dressings were changed.The next follow-up was scheduled for one month.

Manufacturer Narrative

Cvrx id# (b)(6).

Event Description

On (b)(6) 2023, the patient reported that the lead was exposed, and new drainage had been present at the pocket incision for approximately one week.A revision procedure occurred on (b)(6) 2023.The pocket was not infected and mostly healed.The lead was protruding from the patient, and discharge was present at that location.Both leads were cut above the signs of infection, and the cut lead portions were removed.The wounds were irrigated, and wound vac was applied, and the patient was prescribed oral antibiotics for two weeks.As of (b)(6) 2023, the patient was healing well, but the wound vac was still in place.The opinion of the healthcare professional was that the home nurse was applying too much pressure on the gauze as the wound is still deep.The home nurse was subsequently instructed to not apply pressure to the wound and gauze.Prior cultures taken had multiple gram negative and positive methicillin-susceptible staph organisms.On (b)(6) 2023, the wound vac was discontinued, and hydrogel dressings were changed.As of (b)(6) 2023, the patient's wound was healed.

• Brand Name: BAROSTIM NEO LEGACY
• 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: 16381939
• MDR Text Key: 309609104
• Report Number: 3007972010-2023-00004
• Device Sequence Number: 1
• Product Code: DSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H130007
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2011
• Device Model Number: 1010R
• Device Catalogue Number: 100030-001
• Device Lot Number: 120211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2009
• 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 Sex: Male