MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 300

Model Number 300-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

The patient was referred for vns replacement due to battery depletion.The explanted devices were returned to the manufacturer for analysis where it was found the lead had abraded openings in both the inner and outer tubing which coincided with lead coil break locations.Scanning electron microscopy was used and identified extensive pitting at some of the break locations.One break location showed evidence of a stress fracture (fatigue in appearance), with mechanical damage and no pitting.Another break was identified as being mechanically damaged, which prevented the identification of the fracture type; no pitting was observed at this locations.Based on the findings in the pa lab, there was evidence to suggest a discontinuity in the returned portions of the lead.The in-house programming history database was reviewed and it was found to contain information from the patient's date of implant through (b)(6) 2012.The last full system diagnostics were run in 2007 and showed the device was working as intended at that time.

• Brand Name: LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6383937
• MDR Text Key: 69273610
• Report Number: 1644487-2017-03336
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2006
• Device Model Number: 300-20
• Device Lot Number: 011190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 19 YR