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

Model Number 2102

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

Patient Problems Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)

Event Date 08/31/2022

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 record and sterilization record for these device serial numbers have been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The devices met material, assembly, and quality control requirements.Cvrx id: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.On (b)(6) 2022, the patient contacted their physician stating the ipg pocket was red, painful, swollen, and hot starting on (b)(6) 2022.The patient was prescribed antibiotics.On (b)(6) 2022, the pocket appeared worse compared to (b)(6) 2022, but the patient stated it appeared better than a few days prior.Additional antibiotics were prescribed.On (b)(6) 2022, purulent drainage was expressed from the pocket, and continuation of antibiotics and observation was planned.On (b)(6) 2022, it was noted that the patient had completed antibiotics, and mild erythema and some fluid was observed at the non-tender pocket.A follow-up was scheduled.On (b)(6) 2022, mild redness was observed at the pocket and antibiotics were continued.On (b)(6) 2022, the ipg was explanted and the csl was capped.Cultures showed a staphylococcus epidermidis infection.The root cause of the infection was unable to be determined.Recovery will be monitored.

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.On (b)(6) 2022, the patient contacted their physician stating the ipg pocket was red, painful, swollen, and hot starting on (b)(6) 2022.The patient was prescribed antibiotics.On (b)(6) 2022, the pocket appeared worse compared to on (b)(6) 2022, but the patient stated it appeared better than a few days prior.Additional antibiotics were prescribed.On (b)(6) 2022, purulent drainage was expressed from the pocket, and continuation of antibiotics and observation was planned.On (b)(6) 2022, it was noted that the patient had completed antibiotics, and mild erythema and some fluid was observed at the non-tender pocket.A follow-up was scheduled.On (b)(6) 2022, mild redness was observed at the pocket and antibiotics were continued.On (b)(6) 2022, the ipg was explanted and the csl was capped.Cultures showed a staphylococcus epidermidis infection.The root cause of the infection was unable to be determined.As on (b)(6) 2022, the infection had cleared, and the patient was approved to be re-implanted with a new barostim system.

• Brand Name: BAROSTIM NEO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• 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: 15736593
• MDR Text Key: 303148290
• Report Number: 3007972010-2022-00017
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2024
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Race: White