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 Inflammation (1932); Ischemia (1942)

Event Date 02/28/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6) 2023.Two weeks after implant, a follow-up occurred, and the stitches looked good, but the area around the pocket incision was inflamed.The patient was started on oral antibiotics.The patient returned two weeks later for "stitches" removal, and the pocket incision was still inflamed.The patient was prescribed over the counter cream and instructed to finish their course of antibiotics and return in two weeks for wound cleaning.On (b)(6) 2023, the pocket was opened, and the area was cleaned using cautery and saline solution.A portion of tissue was removed with the cautery.The physician stated that the area removed was probably ischemic as a portion of skin may have been higher on one side when doing the stitches, causing an ischemic event.The removed tissue was not sent for culture.No puss-like fluid was observed.Additional oral antibiotics were prescribed.At follow-up appointment on (b)(6) 2023, the infection had cleared, stitches were removed, and the patient was doing well.

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 event was possibly related to stitches being higher on one side of the suture.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).

• 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: 16615057
• MDR Text Key: 312009693
• Report Number: 3007972010-2023-00007
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)240428
• 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
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2024
• 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: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Race: White