MAUDE Adverse Event Report: BAROSTIM NEO; CAROTID SINUS LEAD

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

Patient Problems Nerve Damage (1979); Speech Disorder (4415)

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6) 2023.After the procedure, the patient experienced tongue movement issues where it was difficult to move their tongue to the right side of the mouth.It was noted that the tongue movement difficulty impacted the patient's daily life through difficulty eating and speaking.The patient also experienced one occurrence of lightheadedness.An ent consult was performed, and, in the opinion of the ent, the tongue issue could take six months to one year to resolve.As of (b)(6)2023, the patient reported their speech and tongue movements had improved.The improvement was not 100%, but the patient reported feeling better.

Manufacturer Narrative

Note: initial report inadvertently filed under 3007972023-2023-00023.This is follow-up #001 to that report.Cvrx id# (b)(4).

• Brand Name: BAROSTIM NEO
• Type of Device: CAROTID SINUS LEAD
• MDR Report Key: 17435310
• MDR Text Key: 320161361
• Report Number: 3007972010-2023-00023
• Device Sequence Number: 1
• Product Code: DSR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Date Manufacturer Received: 07/23/2023
• Patient Sequence Number: 1