MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; IMPLANTABLE PULSE GENERATOR

Model Number 2102

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

Patient Problems Dysphagia/ Odynophagia (1815); Sore Throat (2396); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

The reported ipg was received at cvrx on (b)(6) 2023.The paperwork returned with the device gave no indication there was a complaint associated with the explant.During device analysis, the device was found to be acceptable product with no product issues observed.The device history and sterilization 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.H6: health effect clinical code 4581: suggested code "annoying side effects" cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2021.The patient experienced "annoying side effects," and the ipg and lower portion of the csl were explanted on (b)(6) 2022.

Manufacturer Narrative

Cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2021.The patient experienced "annoying side effects," including dysphagia, throat soreness, and voice hoarseness starting on (b)(6) 2021.The ipg and lower portion of the csl were explanted on (b)(6) 2022.The patient's side effects resolved following device explantation.

• Brand Name: BAROSTIM NEO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• 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: 17085551
• MDR Text Key: 316859086
• Report Number: 3007972010-2023-00024
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)230630
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White