MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Injury (2348)

Event Date 12/15/2005

Event Type  Injury  

Event Description

Initially, it was reported that during a vns system replacement surgery, it was observed that the patient's left vagus nerve was cut and that it presented with signs of having been cut for a long period of time.A neuroma was observed at the level of the cut which was at the lower end of the vagus nerve.No relationship of the cut to vns was noted at the time of initial report.It was later reported during a neurosurgeon expert meeting, that the diagnosis of a complete cut left nervus vagus with a neuroma was made during the replacement surgery.It was noted that the lesion was probably due to direct surgical trauma during the first implant procedure.It was noted that the patient had experienced partial improvement of epilepsy with vns therapy.

• Brand Name: LEAD MODEL 302
• 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: 3774040
• MDR Text Key: 20265218
• Report Number: 1644487-2014-01121
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2005
• 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: 20 YR