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

Model Number 1036

Device Problem Material Twisted/Bent (2981)

Patient Problem Twiddlers Syndrome (4563)

Event Date 01/11/2024

Event Type  Injury  

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 twiddling of the device by the patient.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.Cvrx id# (b)(4).

Event Description

On 18-dec-2023, it was reported that the patient experienced extraneous stimulation in their neck, face and arm.The patient's device was noted for twiddling and a revision was scheduled for (b)(6) 2024.The patient was scheduled to have their device turned off on (b)(6) 2023 until the revision procedure was completed.It was reported that on (b)(6) 2024, the patient successfully underwent secondary surgery to untwist their device.Since the procedure, the patient was seen twice for routine follow-ups with no additional concerns reported.

Manufacturer Narrative

The investigation findings was changed from no findings available to more appropriate code of usage problem identified.Cvrx id# (b)(6).

• 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: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 18881221
• MDR Text Key: 337407334
• Report Number: 3007972010-2024-00006
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)250105
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2023
• 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: 67 YR
• Patient Sex: Female