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 Hematoma (1884); Post Operative Wound Infection (2446)

Event Date 04/26/2023

Event Type  Injury  

Event Description

A barostim system was implanted approximately on (b)(6) 2023.An infection was experienced starting on (b)(6) 2023, and on (b)(6) 2023, it was reported that the patient had been admitted to the hospital with a pocket infection.Culture results showed a staphylococcus aureus infection.An ipg explant was performed on (b)(6) 2023, and iv antibiotic treatment was planned for several weeks.In the opinion of the physician, the pocket infection was likely related to a hematoma the patient had experienced after the implant surgery.Additional information regarding the hematoma was unavailable.

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.Cvrx id# (b)(4).

Event Description

A barostim system was implanted approximately on (b)(6) 2023.An infection was experienced starting on (b)(6) 2023, and on (b)(6) 2023, it was reported that the patient had been admitted to the hospital with a pocket infection.Culture results showed a staphylococcus aureus infection.An ipg explant was performed on (b)(6) 2023, and iv antibiotic treatment was planned for several weeks.In the opinion of the physician, the pocket infection was likely related to a hematoma the patient had experienced after the implant surgery.Additional information regarding the hematoma was unavailable.As of (b)(6) 2023, the patient remained in the hospital but was fever free.The patient was discharged home on (b)(6) 2023.

Manufacturer Narrative

Cvrx id# (b)(4).

• 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: 16991807
• MDR Text Key: 315854860
• Report Number: 3007972010-2023-00021
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004005
• UDI-Public: (01)00859144004005(17)240906
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P180050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2102
• Device Catalogue Number: 100054-201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: White