MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number 303-20

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

Patient Problems Dyspnea (1816); Ecchymosis (1818); Paresis (1998)

Event Date 02/28/2017

Event Type  Injury  

Event Description

It was reported that a patient began experiencing an inspiratory stridor after vns implant surgery that did not resolve after about two weeks.The patient's physician ordered chest x-rays and opted to leave the device programmed off due to the event.The patient was seen by an ent who stated that there was bruising on the left vagus nerve and that the patient had paresis of the left vocal cord.The patient's physician believed the bruising of the nerve and the vocal cord paresis were both related to surgery due to the manipulation of the vagus nerve that took place during implant.A review of the manufacturing records for the implanted lead confirmed it had passed all quality inspections prior to release for distribution and was sterilized per specifications prior to release for distribution.The surgeon also indicated that the post-op impedance values were within normal limits.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6535105
• MDR Text Key: 74115999
• Report Number: 1644487-2017-03703
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Model Number: 303-20
• Device Lot Number: 300463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• 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): Other
• Patient Age: 11 YR