MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Extrusion (2934)

Patient Problem Twiddlers Syndrome (2114)

Event Date 10/01/2015

Event Type  Injury  

Event Description

It was reported that the vns patient was picking at the neck incision site and subsequently caused extrusion of the lead.The patient underwent surgery on (b)(6) 2015 and the patient's lead was replaced prophylactically.During the procedure, the patient's generator was inadvertently hit by electrocautery and the device subsequently showed a vbat < eos threshold message.Battery status prior to surgery showed ok.The generator was also replaced during the procedure.The explanted lead has been returned to the manufacturer where analysis is currently underway.Analysis of the returned lead will be reported in this manufacturer report.The explanted generator was returned to the manufacturer for analysis which was reported in manufacturer report # 1644487-2015-06497.

Event Description

Analysis of the returned lead was completed.Scanning electron microscopy images of the lead coils at the exposed portions and at the cut ends show that the coils were exposed some type of electro-cautery tool.Based on the appearance of the returned lead this was most likely caused at explant.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead.

• 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: 5238025
• MDR Text Key: 31673963
• Report Number: 1644487-2015-06498
• 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: Initial,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: 304-20
• Device Lot Number: 3923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• 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: 13 YR