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

Model Number 1036

Device Problems Low impedance (2285); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  Injury  

Event Description

A patient had a upper back and neck chiropractic adjustment in (b)(6) of 2022.On (b)(6) 2022, records showed a drop in impedance occurred on (b)(6) 2022 which correlated with the adjustment.X-rays were performed, and the csl lead insulation appeared torn at the mid-neck level.The csl was also twisted and wrapped around itself, which indicated that the patient twiddled with their device.It was noted that the ipg had been sutured with two sutures at the initial implant procedure.A csl replacement occurred on (b)(6) 2022, and it was noted that the ipg sutures were still intact on the ipg but had pulled out of the tissue.A new ipg was placed subpectorally and resutured.The patient was doing well following the procedure.

Manufacturer Narrative

The ipg and a portion of the csl were returned for analysis.The ipg functioned as intended.No analysis was able to be performed on the csl, as only a portion was returned, so csl analysis was inconclusive.Based on the information received, the cause of the reported event was related to twiddling and a chiropractic adjustment.The device history record and sterilization record for these device serial numbers have been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The devices met material, assembly, and quality control requirements.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: 15695667
• MDR Text Key: 302690810
• Report Number: 3007972010-2022-00016
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)231005
• 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
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/05/2023
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 79 YR
• Patient Sex: Female
• Patient Race: White