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

Model Number 2104

Device Problem Unintended Movement (3026)

Patient Problem Discomfort (2330)

Event Date 04/05/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6) 2022.The patient experienced a scratchy throat, hoarse voice, and the need to clear their throat.On (b)(6) 2023, an x-ray was performed.It was observed that the ipg had flipped in the submuscular pocket.The ipg had been sutured with two sutures at the initial implant.It was unknown how the device flipped in the pocket.A revision occurred on (b)(6) 2023.The ipg was moved from the right submuscular pocket to the left side inferior to the armpit.The lead was tunneled to the new ipg location.No interaction was observed with the patient's crm device during interaction testing.The barostim system functioned normally after reconnection and testing.As of (b)(6) 2023, the incisions were healing well, and the patient was doing well.Barostim therapy was adjusted, and the throat and voice issues were resolved.

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.Prior ipg movement events for this patient were reported under 3007972010-2022-00020 and 3007972010-2022-00023.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 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: 17003825
• MDR Text Key: 315945094
• Report Number: 3007972010-2023-00019
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)240223
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2024
• 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: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Race: White