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

Model Number 2102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neck Pain (2433); Implant Pain (4561)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device has not been returned for analysis.Based on the information received, the cause of the reported event could not be conclusively deteremined.Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis in completed.Cvrx #: (b)(4).

Event Description

Following implant of the barostim system on (b)(6) 2020, the patient experienced chronic pain at the device pocket incision and the electrode incision in the neck.A referral was made to a pain specialist, but the pain was not resolved.The patient was unwilling to try to turn off therapy for one to two weeks.A system explant was performed on (b)(6) 2021.No issues or complications with the device operation were reported.

Manufacturer Narrative

The reported ipg and csl were returned to cvrx for analysis.No damage was visible on the ipg.The ipg device logs were reviewed, no events had occurred, and the ipg had not reached eos.The ipg functioned as intended.The csl was received cut approximately 4 inches from the terminal pin.Three cuts were observed on the silicone insulation material 3-4 inches from the terminal pin.The cuts were likely present during explant based on the fluid ingression inside the lead body.There was a 1.5 inch kink approximately 9inches from the electrode end of the csl.No functional tests were able to be performed on the csl due to the csl being cut.The ipg and csl functioned as intended, and there was no indication that the ipg or csl malfunctioned.At the conclusion of the device analysis, the reported event was unable to be conclusively confirmed.The device history records for this ipg and csl 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
• MDR Report Key: 12481038
• MDR Text Key: 271693074
• Report Number: 3007972010-2021-00003
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)220212
• Combination Product (y/n): N
• PMA/PMN Number: P180050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 84