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

Model Number 302-20

Device Problems Retraction Problem (1536); Low impedance (2285)

Patient Problem No Code Available (3191)

Event Date 10/28/2015

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery for end of service the surgeon disconnected the generator from the lead and then attempted to pull the lead from the patient's back side to re-tunnel the lead to the chest area.When the surgeon pulled the lead it got hung up in the patient's body and when the surgeon pulled on it the lead wires started retracting in the tubing.A new generator was attached to the lead and device diagnostics showed low impedance (<600 ohms).The surgeon did not obtain consent for lead replacement, so the lead was cut and explanted and a new generator was not placed.The patient was closed and rescheduled for lead replacement.No known surgical interventions have been performed to date.

Event Description

It was reported that the explanted devices were discarded; therefore, no product analysis can be performed.An implant card was received indicating that the patient underwent generator and lead reimplant on (b)(6) 2015.The surgeon indicated that he believed the lead electrodes were not on the nerve which he identified while dissecting the lead electrodes off of the nerve to reimplant the new lead.The surgeon indicated that the patient's anatomy was a little different than normally seen and an ultrasound was used to help determine the lead placement.The new generator was placed at the patient's chest.Device diagnostics were within normal limits.

• 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: 5220659
• MDR Text Key: 31241072
• Report Number: 1644487-2015-06405
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2012
• Device Model Number: 302-20
• Device Lot Number: 201037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2009
• 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 Age: 49 YR