MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-30

Device Problem Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 09/03/2015

Event Type  malfunction  

Event Description

It was reported that the patient was having pain at her vns generator implant site and thus was wanting the device repositioned.No known surgical interventions have occurred to date.No additional relevant information has been obtained to date.

Event Description

Additional information was received that the patient was hyper-sensitive to the pain, so initially it was believed that there was nothing wrong other than the presence of the device causing pain.It was reported that the patient underwent generator replacement surgery on (b)(6) 2015 due to the chest pain as well as painful stimulation.Pre-operative diagnostics revealed normal impedance of 1,590 ohms.During the replacement surgery, the surgeon observed a crack in the lead insulation with some fluid inside.There was no known trauma which caused this.The lead was not revised.

• 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: 5106217
• MDR Text Key: 26828353
• Report Number: 1644487-2015-05903
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2009
• Device Model Number: 302-30
• Device Lot Number: 200104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2006
• 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): Required Intervention
• Patient Age: 37 YR