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

Model Number 1036

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Twiddlers Syndrome (4563)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

While the reported device was not returned for analysis, the root cause of the event was reported to be 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.The expiration date of the csl is not autofilling in the report form.The expiration date is 10-oct-2023.Cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2021, and the system was sutured with six sutures around the electrode, two on the strain relief tab, and two in the ipg header.On (b)(6) 2022, the patient fell on their right side, where the barostim system had been implanted.The patient experienced pain and that "something wasn't right." an x-ray was taken at the emergency department, which the physician reported to look visually good, and the patient was discharged home with no bruising or swelling.On (b)(6) 2022, the patient still did not feel as well as they did in earlier therapy, and there had been a 10% decrease in ef.The patient was not in acute distress and was alert and orientated.The system was interrogated, and seemed to be functioning, and the lead impedance was similar to the lead impedance prior to the fall.Additional x-rays of the carotid were planned.It was noted from the x-rays that the lead was balled resembling a lead that had been twiddled.A lead revision occurred on (b)(6) 2022, and twiddling was confirmed.The lead revision was successful, and the ipg was placed subpectorally in an attempt to prevent future twiddling.

• 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: 15394309
• MDR Text Key: 299659890
• Report Number: 3007972010-2022-00013
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)2310005
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White