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

Model Number 302-20

Device Problems High impedance (1291); Device Displays Incorrect Message (2591)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Clinic notes dated (b)(6) 2014 note vns nearing end of service and lead impedance increased.The notes indicate that the patient will be referred for vns replacement.The physician reported that on interrogation of the device two messages were received indicating that the device was nearing end of life and the lead impedance had increased.Review of device labeling showed that there is not a message that can be received upon interrogation of a model 102 generator that indicates anything about increased impedance.It appears that the physician performed device diagnostics, but is misinterpreting the results.The patient underwent generator and lead replacement and it was reported that device diagnostics were performed without error.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

The generator was received with its battery depleted.Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition.The device performed according to functional specifications.No abnormal performance or any other type of adverse condition was found with the generator.The returned lead portion has dried remnants of what appear to have once been body fluids inside the inner silicone tubing.No obvious point of entrance was noted other than the end of the returned lead portion.Incisions in the silicone tubing of the negative coil were necessary to perform proper inspection of the coil.A break was identified at the end of the negative coil.Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the broken strand and the coil end.Also, a secondary break was identified in one strand of the quadfilar coil in the vicinity of the broken end.However, due to metal dissolution and/or surface contamination the fracture mechanism of the broken wires cannot be determined.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.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description

The generator and lead were returned for analysis on (b)(4) 2014.Analysis is underway, but has not been completed to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3727274
• MDR Text Key: 4327607
• Report Number: 1644487-2014-00898
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2010
• Device Model Number: 302-20
• Device Lot Number: 200487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2007
• 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: 15 YR