MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; CAROTID SINUS LEAD

Model Number 1036

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

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 02/12/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient experienced redness at the neck incision, and the incision was warm to the touch and yellow and pink drainage was present.The infected area was 9x3 centimeters.The patient was instructed to go to the emergency room by their physician where a blood draw was taken, which indicated high white blood cells.No cultures were performed.An ultrasound showed a pocket infection.The patient was admitted to hospital on (b)(6) 2023 as a proactive measure and will receive iv antibiotics.The barostim system was explanted on (b)(6) 2023, and a drain was located at the neck incision site, with approximately 80cc of fluid drainage in the 36 hours following the explant.The drainage was described as pink, yellow, clumps with the appearance of cottage cheese.As of (b)(6) 2023, the patient remained on iv antibiotics.The patient was discharged on (b)(6) 2023, and with an additional two weeks of oral antibiotics.A check-up and stitch removal appointment was scheduled for (b)(6) 2023.It was noted that the patient had facial hair that they were unwilling to shave for the implant procedure.Operating room staff had been instructed to clean the surgical site and find a way to move facial hair away from the site for draping.The staff used iodine at the surgical site and waited an undetermined length of time before beginning the procedure.The cardiologist felt a hair follicle had gotten into the incision site and may have caused the infection.It was noted by the patient that the infection disease specialist informed them the infection showed signs of being a water-born bacteria.The patient had a water well without a filtration system.

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 facial hair and a water borne bacteria.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 system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient experienced redness at the neck incision, and the incision was warm to the touch and yellow and pink drainage was present.The infected area was 9x3 centimeters.The patient was instructed to go to the emergency room by their physician where a blood draw was taken, which indicated high white blood cells.No cultures were performed.An ultrasound showed a pocket infection.The patient was admitted to hospital on (b)(6) 2023 as a proactive measure and will receive iv antibiotics.The barostim system was explanted on (b)(6) 2023, and a drain was located at the neck incision site, with approximately 80cc of fluid drainage in the 36 hours following the explant.The drainage was described as pink, yellow, clumps with the appearance of cottage cheese.As of (b)(6) 2023, the patient remained on iv antibiotics.The patient was discharged on (b)(6) 2023, and with an additional two weeks of oral antibiotics.On (b)(6) 2023, pus was still present at the incision site, and the patient was prescribed another round of oral antibiotics.On (b)(6) 2023, it was confirmed that the infection had cleared.While the root cause was unable to be determined, it was noted that the patient had facial hair that they were unwilling to shave for the implant procedure.Operating room staff had been instructed to clean the surgical site and find a way to move facial hair away from the site for draping.The staff used iodine at the surgical site and waited an undetermined length of time before beginning the procedure.The cardiologist felt a hair follicle had gotten into the incision site and may have caused the infection.It was noted by the patient that the infection disease specialist informed them the infection showed signs of being a water-born bacteria.The patient had a water well without a filtration system.It was also noted the patient had an infection in several of their cracked teeth.

Manufacturer Narrative

Cvrx id# (b)(4).

• Brand Name: BAROSTIM NEO
• Type of Device: CAROTID SINUS LEAD
• 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: 16539132
• MDR Text Key: 311248924
• Report Number: 3007972010-2023-00006
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)231109
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/09/2023
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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
• Treatment: CVRX IPG 2102004207
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male