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

Model Number 2102

Device Problem Use of Device Problem (1670)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

While analysis was unable to be performed as the device was not returned, the root cause of the event was related to device being inadvertently programmed too high.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

On 29-jan-2024, it was reported that the patient experienced extraneous stimulations in the form of their voice changing and also some coughing.The patient will be seen for an already scheduled titration visit on (b)(6) 2024 and a discussion will be had with the physician on how to address the patients concerns.The patient mentioned that their energy levels has greatly improved.The patient was seen on (b)(6) 2024 with a noticeable cough and an occasional voice alteration.The patient described the feeling as uncomfortable and reported that the symptoms began shortly after their last follow-up visit on (b)(6) 2024.However, the patient requested to have their setting increased as they have noticed improvements in their heart failure symptoms.Temporarily inhibiting the therapy did not result in complete resolution of the cough but there was some improvement.The cough seems to be position related and was easily induced by moving the head to the right.The physician asked to keep the settings as they are until the patient sees an ears nose and throat specialist.The option to reduce the pulse width was presented but the physician preferred not to.On 13-feb-2024, it was reported that the patient was seen for an unscheduled visit with their ent on (b)(6) 2024.The patient received a nerve block and was placed on gabapentin.The patient reported that the nerve block only helped about 10 percent.The physician also suggested turning off therapy for 24-48 hours to see if the symptoms will resolve.Therapy was turned off on (b)(6) 2024.The patient's cough and voice alterations resolved, however the patient had less energy.Therapy was restarted on (b)(6) 2024 with adjustments, and the patient's symptoms did not recur.On (b)(6) 2024, the patients therapy amplitude was programmed at 4ma and the physician instructed the patient to increase their gabapentin levels and return for evaluation which was scheduled for (b)(6) 2024.On (b)(6), the patients therapy amplitude was increased to 5.2ma and there was no apparent increase in cough or voice alteration and no extraneous stimulation.The patient was scheduled to be seen on (b)(6) 2024 for a regular follow-up appointment.

• 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: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 18912604
• MDR Text Key: 337761793
• Report Number: 3007972010-2024-00009
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004482
• UDI-Public: (01)00859144004482(17)240914
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 100054-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White