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

Model Number 1036

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Neck Pain (2433); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2022

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 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.(b)(4).Cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.During a follow-up on (b)(6) 2022, the patient reported experiencing a shocking sensation at 8:38 am every day through their neck to the back of their head, and the patient's neck was observed to be swollen.During device interrogation and impedance testing, the patient experienced a shocking sensation in their head and jaw.Therapy was turned off to allow the patient additional time to heal before activating the system.An ultrasound identified fluid build up in the neck inferior to the electrode position.The device was reactivated and reprogrammed on (b)(6) 2022.On (b)(6) 2022, the fluid in the neck was drained.The cause of the fluid build-up and type of fluid present was unknown.It was noted that the patient had a history of hematoma following prior icd implants.It was also noted that the fluid could have been contributing to the stimulation the patient experienced.Following the reprogramming and fluid removal, the patient reports only a slight sensation at 8:40 am and was feeling well.

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.During a follow-up on (b)(6) 2022, the patient reported experiencing a shocking sensation at 8:38 am every day through their neck to the back of their head, and the patient's neck was observed to be swollen.During device interrogation and impedance testing, the patient experienced a shocking sensation in their head and jaw.Therapy was turned off to allow the patient additional time to heal before activating the system.An ultrasound identified fluid build up in the neck inferior to the electrode position.The device was reactivated and reprogrammed on (b)(6) 2022.On (b)(6) 2022, the fluid in the neck was drained.The cause of the fluid build-up and type of fluid present was unknown.It was noted that the patient had a history of hematoma following prior icd implants.It was also noted that the fluid could have been contributing to the stimulation the patient experienced.Following the reprogramming and fluid removal, the patient reports only a slight sensation at 8:40 am and was feeling well.As of on (b)(6) 2023, the patient reported a much more tolerable sensation every morning.Therapy was increased with no reported impact to the patient.As of on (b)(6) 2023, the sensation was getting weaker, and therapy was increased with the patient remaining comfortable.No additional intervention was planned.

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.During a follow-up on (b)(6) 2022, the patient reported experiencing a shocking sensation at 8:38 am every day through their neck to the back of their head, and the patient's neck was observed to be swollen.During device interrogation and impedance testing, the patient experienced a shocking sensation in their head and jaw.Therapy was turned off to allow the patient additional time to heal before activating the system.An ultrasound identified fluid build up in the neck inferior to the electrode position.The device was reactivated and reprogrammed on (b)(6) 2022.On (b)(6) 2022, the fluid in the neck was drained.The cause of the fluid build-up and type of fluid present was unknown.It was noted that the patient had a history of hematoma following prior icd implants.It was also noted that the fluid could have been contributing to the stimulation the patient experienced.Following the reprogramming and fluid removal, the patient reports only a slight sensation at 8:40 am and was feeling well.As of on (b)(6) 2023, the patient reported a much more tolerable sensation every morning.Therapy was increased with no reported impact to the patient.

• Brand Name: BAROSTIM
• 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: 16105978
• MDR Text Key: 306785344
• Report Number: 3007972010-2023-00001
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)240629
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: 61 YR
• Patient Sex: Male