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

Model Number 2104

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 03/24/2023

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 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 implant occurred on (b)(6) 2023.The patient habitually took baby aspirin but no other blood thinners, and had held all medications the morning of (b)(6) 2023 as instructed.The procedure was performed successfully without incident, and the patient was stable throughout the procedure.The patient recovered in the pacu and was released home several hours later.In the evening of (b)(6) 2023, the patient experienced a facial droop on the right side of their face and returned to the hospital and was admitted.Imaging did not find any sign of embolism, and no surgical intervention was performed.In the opinion of the physician, the patient experienced a transient ischemic attack (tia), and expects a full recovery.The patient experienced a hematoma and edema at the csl incision.As of (b)(6) 2023, the edema had resolved and the right mouth droop was improved but not yet resolved.An mri was planned.

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim implant occurred on (b)(6) 2023.The patient habitually took baby aspirin but no other blood thinners, and had held all medications the morning of (b)(6) 2023 as instructed.A carotid ultrasound showed the left side had no stenosis.The procedure was performed successfully on the left carotid without incident, and the patient was stable throughout the procedure.The patient recovered in the pacu and was released home several hours later.In the evening of (b)(6) 2023, the patient experienced a facial droop on the right side of their face and returned to the hospital and was admitted.Imaging did not find any sign of embolism, and no surgical intervention was performed.In the opinion of the physician, the patient experienced a transient ischemic attack (tia), and expects a full recovery.The patient experienced a hematoma and edema at the csl incision.As of (b)(6) 2023, the edema had resolved and, as of (b)(6) 2023, the right mouth droop was improved but not yet resolved.It was noted the barostim therapy had been increased several times with no issues experienced by the patient.

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim implant occurred on (b)(6) 2023.The patient habitually took baby aspirin but no other blood thinners, and had held all medications the morning of on (b)(6) 2023 as instructed.A carotid ultrasound showed the left side had no stenosis.The procedure was performed successfully on the left carotid without incident, and the patient was stable throughout the procedure.The patient recovered in the pacu and was released home several hours later.In the evening of on (b)(6) 2023, the patient experienced a facial droop on the right side of their face and returned to the hospital and was admitted.Imaging did not find any sign of embolism, and no surgical intervention was performed.In the opinion of the physician, the patient experienced a transient ischemic attack (tia), and expects a full recovery.The patient experienced a hematoma and edema at the csl incision.As of on (b)(6) 2023, the edema had resolved and, as of on (b)(6) 2023, the right mouth droop was improved but not yet resolved.It was noted the barostim therapy had been increased several times with no issues experienced by the patient.As of on (b)(6)2023, the mouth droop had not resolved.The patient had an mri and there were no findings of a stroke.As there were no findings on the mri, the opinion of the physician was that the root cause of the mouth droop was unable to be determined.As of on (b)(6)2023, the mouth droop had not resolved, but the patient was doing well and had more energy.The hematoma had also resolved at an unknown date.

• 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: 16764102
• MDR Text Key: 313529582
• Report Number: 3007972010-2023-00012
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)241115
• 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,Followup,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 91 KG