MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 303

Model Number 303-20

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

Patient Problems Feeding Problem (1850); Paralysis (1997); Seizures (2063)

Event Date 07/21/2014

Event Type  Injury  

Event Description

It was reported that the patient had a seizure a month prior and was "out" for 36 hours.The patient reported that it is believed that the seizure may have potentially been a stroke and plans to follow-up with the physician.The patient also reported that it is now difficult to swallow properly and that he has right vocal cord paralysis.Attempts to obtain additional relevant information has been unsuccessful to date.

• Brand Name: LEAD MODEL 303
• 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: 4102868
• MDR Text Key: 4833028
• Report Number: 1644487-2014-02403
• 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: Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2013
• Device Model Number: 303-20
• Device Lot Number: 200321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2006
• 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: 36 YR