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	Fatigue (1849); High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020); Renal Failure (2041); Electrolyte Imbalance (2196); Cardiogenic Shock (2262); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2022.On (b)(6) 2023, the patient reported increased shortness of breath and fatigue, and barostim therapy was increased.On (b)(6) 2023, the patient experienced increased shortness of breath.Due to the shortness of breath, the patient was self-dosing with lasix.Labs were performed, and lasix was discontinued due to cariomems numbers.On (b)(6) 2023, the patient was in distress and directly admitted to the intensive care unit due to cardiogenic shock.A right heart catheterization (rhc) was performed, and results showed elevated pulmonary alveolar proteinosis (pap).Inotropes were administered.Thoracentesis was performed on (b)(6) 2023, and 850ml of fluid was removed.Kidney function was reported to be worsening.Lung arterial pressure were indicative of hypovolemia on (b)(6) 2023, and milrinone was discontinued with volume boluses administered.Barostim therapy was decreased from 9.4 mas to 5.0 mas.Dobutamine was administered, and pleural fluid returned.Bilateral chest tubes were placed on (b)(6) 2023, and filling pressures were reported to be low.The patient was hypertensive, and high dose steroids were administered.The patient was positive for perinuclear anti-neutrophil cytoplasmic antibodies (panca), and there was a concern for vaculitis causing renal failure, and dobutamine was discontinued.A renal biopsy was performed and was negative for vaculitis.The patient had their chest tubes removed and were discharged on (b)(6) 2023.As of (b)(6) 2023, the patient was doing well, and a steroid taper was prescribed.The patient still experienced generalized weakness and was referred to cardiac rehab.In the opinion of the physician, the barostim therapy increase on (b)(6) 2023 caused the patient's blood vessels to "over-dilate" which resulted in too much fluid being stored in vasculature.
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 barostim therapy affecting the patient's blood vessels.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.H6: health effect clinical code 4581: suggested codes are "panca" and "shortness of breath" cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2022.On (b)(6) 2023, the patient reported increased shortness of breath and fatigue, and barostim therapy was increased.On (b)(6)2023, the patient experienced increased shortness of breath.Due to the shortness of breath, the patient was self-dosing with lasix.Labs were performed, and lasix was discontinued due to cariomems numbers.On (b)(6) 2023, the patient was in distress and directly admitted to the intensive care unit due to cardiogenic shock.A right heart catheterization (rhc) was performed, and results showed elevated pulmonary alveolar proteinosis (pap).Inotropes were administered.Thoracentesis was performed on (b)(6)2023, and 850ml of fluid was removed.Kidney function was reported to be worsening.Lung arterial pressure were indicative of hypovolemia on (b)(6) 2023, and milrinone was discontinued with volume boluses administered.Barostim therapy was decreased from 9.4 mas to 5.0 mas.Dobutamine was administered, and pleural fluid returned.Bilateral chest tubes were placed on (b)(6) 2023, and filling pressures were reported to be low.The patient was hypertensive, and high dose steroids were administered.The patient was positive for perinuclear anti-neutrophil cytoplasmic antibodies (panca), and there was a concern for vasculitis causing renal failure, and dobutamine was discontinued.A renal biopsy was performed and was negative for vasculitis.The patient had their chest tubes removed and were discharged on (b)(6) 2023, the patient was doing well, and a steroid taper was prescribed.The patient still experienced generalized weakness and was referred to cardiac rehab.In the opinion of the physician, the patient's comorbidities along with the mechanism of action, including vasodilation, of the barostim therapy and the barostim therapy increase on (b)(6) 2023 exacerbated the retainment of interstitial fluid.
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the patient's comorbidities along with the mechanism of action, including vasodilation, of the barostim therapy and the barostim therapy increase on (b)(6) 2023 exacerbated the retainment of interstitial fluid.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 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis 55445
• MDR Report Key: 17756732
• Report Number: 3007972010-2023-00045
• Device Sequence Number: 15268221
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)240829
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/04/2023

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: 08/29/2024
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White