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

Model Number 1036

Device Problems Fracture (1260); Migration (4003)

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

Event Date 07/08/2023

Event Type  Injury  

Manufacturer Narrative

The reported ipg was received at cvrx for analysis.A supplemental report will be submitted when the device analysis is completed.Cvrx id# (b)(4).

Manufacturer Narrative

The reported ipg and csl were received at cvrx for analysis.A visual inspection of the ipg revealed no physical damage.There was a single suture in each suture hole of the ipg indicating the ipg had been sutured into tissue and had pulled out of the tissue.The csl was received in three pieces.Growth was present on the lead, and the silicone tubing was significantly yellowed.The distal section was 7-8 inches in length, does not appear to have an insulation breach, and was twisted near the molded transition.The lead appears to be cut.The middle section of the csl appeared to be cleanly cut at one end through the tubing and coil, which is most likely associated with being cut with a tool to aid the explant.This cut matched the cut on the distal portion of the lead.The other end of the middle section of the csl appeared torn and did not exhibit any signs of a cut made by a tool.The coils of the proximal section of the csl were stretched significantly and there was significant twisting of the coils.The cause of the twisting was unable to be determined, and it wasn't clear if the twisting was a result of twiddling or caused during explant.At the conclusion of the analysis, it was confirmed that the ipg sutures had pulled out and the lead was damaged.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 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis 55445
• MDR Report Key: 18759765
• MDR Text Key: 340809175
• Report Number: 3007972010-2024-00002
• Device Sequence Number: 1
• Product Code: DSR
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2024
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2022
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 142 KG
• Patient Race: Black Or African American