MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problem Paralysis (1997)

Event Date 11/05/2013

Event Type  Injury  

Event Description

It was reported that the patient has been speaking at a whisper ever since implant and that the neurologist believes the patient has vocal cord paralysis.It was reported that the surgeon does not believe that the patient's vocal cords will stay this way.The physician believes that this is related to the vns implant surgeon and will be evaluating the patient further to see if the symptoms improve.The patient's settings were adjusted, but it was reported that the patient's voice was still at a whisper.Attempts to obtain additional information will be made, but not additional information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS INC; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS INC; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 3578970
• MDR Text Key: 19970572
• Report Number: 1644487-2014-00261
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 202587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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: 16 YR