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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Neck Pain (2433)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

Analysis of the returned generator and lead was completed.The generator performed according to functional specifications.There were no anomalies found with the pulse generator.Analysis confirmed discontinuity of the positive quadfilar coil in the body region of the returned lead portions.An abraded opening of the positive inner tubing was observed near the break area.Scanning electron microscopy was performed on the connector end of the quadfilar coil break and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting.Pitting was observed on the coil surface.

Manufacturer Narrative

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

Event Description

It was reported that the vns patient presented with neck pain.The patient¿s device was tested and diagnostic results showed high impedance.The patient¿s device was subsequently disabled.Since device disablement, the patient experienced a seizure while previously being seizure-free.Follow-up revealed that high impedance was observed on both normal mode and system diagnostic tests.The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

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

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance.The explanted devices have been returned to the manufacturer where analysis is currently underway.

• 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: 4651958
• MDR Text Key: 5796673
• Report Number: 1644487-2015-04352
• 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: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Model Number: 302-20
• Device Lot Number: 201541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2010
• 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: 29 YR