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

Model Number	2102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Unspecified Heart Problem (4454)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2023, the patient experienced a headache.They were started on fioricet, and had an appointment with their neurologist.As of (b)(6) 2023, the headache had resolved.The opinion of the barostim physician was that the headache was related to the barostim system.On (b)(6) 2023, it was reported that the patient had been hospitalized for heart issues and shortness of breath.It was not known if the hospitalization or heart issues were related to the barostim system or therapy.The patient was placed on the transplant list.
Event or Problem Description
On (b)(6) 2023, the patient experienced a headache.They were started on fioricet, and had an appointment with their neurologist.As of on (b)(6) 2023, the headache had resolved.The opinion of the barostim physician was that the headache was related to the barostim system.The patient had been hospitalized for heart failure decompensation, including shortness of breath, on (b)(6) 2023.While hospitalized, the patient was compensated with medications, and the barostim system therapy was increased.The patient was released on (b)(6) 2023.It was not known if the hospitalization or heart issues were related to the barostim system or therapy.The patient was placed on the transplant list.As of on (b)(6) 2023, in the opinion of the physician, the root cause of the patient's hospitalization was decompensation related to their pre-existing heart failure and was not caused or contributed to by the barostim system.As of on (b)(6) 2023, the patient was doing well.
Additional 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 the patient's pre-existing condition.Cvrx id#: (b)(4).

• Brand Name: BAROSTIM NEO
• Common Device Name: 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: 16815922
• Report Number: 3007972010-2023-00014
• Device Sequence Number: 14876733
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)230720
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/20/2023
• Device Model Number: 2102
• Device Catalogue Number: 1000054-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic