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

Model Number 1036

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

While the analysis results of the investigation are inconclusive since the reported device was not returned for analysis, the site reported that the lead was cut accidentally by a physician during the procedure.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

An ipg replacement was scheduled for on (b)(6) 2022 due to normal battery depletion.An x-ray was performed prior to the procedure, and it was noted that lead loops were located on the lateral and medial sides of the ipg, and there was also a loop above the ipg.When the physician opened, they accidentally cut the lead.The ipg replacement was cancelled.It was planned to bring the patient back at a later date to repair the lead and replace the ipg.No patient adverse event was reported.A lead repair procedure was performed on (b)(6) 2022, and the lead repair and ipg replacement were successful.No additional patient adverse events were reported.The patient was discharged home with no reported complications.

• 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: 13789898
• MDR Text Key: 287538764
• Report Number: 3007972010-2022-00004
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004265
• UDI-Public: (01)00859144004265(17)200328
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 1036
• Device Catalogue Number: 100063-211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 85 KG