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

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 12/07/2015

Event Type  malfunction  

Event Description

It was reported that the patient's vns device showed high lead impedance on (b)(6) 2015.X-rays were taken and the radiologist identified a lead fracture, although the neurologist did not visualize a fracture.It was stated that the patient was still receiving efficacy from vns magnet swipes.Device manufacturing records were reviewed and found all specifications met prior to distribution.The patient underwent generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and lead fracture.The explanted generator and lead have been received by the manufacturer for analysis.However, analysis has not been completed to date,.

Event Description

Analysis of the returned generator and lead was completed.Analysis of the generator revealed no observed anomalies.The generator performed according to functional specifications in the analysis lab.Review of the associated generator data showed that the impedance value changed from a value of 14,048 ohms to 21,979 ohms on the day after surgery.Analysis of the returned lead showed abraded openings on the outer tubing.A coil break was identified in both positive and the negative lead coils.Scanning electron microscopy images of the positive and the negative coil show that pitting or electro-etching conditions have occurred at the break location.Appearance of the negative coil suggests a stress-induced fracture occurred in at least one strand.However, due to metal dissolution, surface contamination and/or mechanical distortion (smoothed surfaces) the fracture mechanism of other strands cannot be ascertained.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.No additional relevant information has been received to date.

• 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: 5332681
• MDR Text Key: 35170643
• Report Number: 1644487-2015-06857
• 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: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: 304-20
• Device Lot Number: 3729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• 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: 3 YR