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 Paralysis (1997); No Code Available (3191)

Event Date 01/23/2018

Event Type  Injury  

Event Description

It was reported that a patient had concerns with her voice alteration and feeling of something lodged in her throat.She had stated she had seen her surgeon who stated nothing was wrong but planned to follow up with the neurologist.Follow up with the physician's office noted that the patient had been seen since implant and the device had been turned on.The adverse events were also reported to his office and the patient was referred to the ent for evaluations because the events were not occurring with stimulation.Diagnostics were requested but not provided.Programming history data was reviewed and data observed was from the date of implant, showing no apparent device malfunctions.Further communication was received stated that the patient's vocal cords were "completely not working".No further relevant information was received to date.

• 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: 7889639
• MDR Text Key: 120731770
• Report Number: 1644487-2018-01646
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2020
• Device Model Number: 303-20
• Device Lot Number: 5134
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• 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: 46 YR