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

Model Number 302-20

Device Problems High impedance (1291); Kinked (1339); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

Analysis of the returned lead portion was completed which confirmed discontinuity of negative quadfilar coil in the body region.Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location.Abraded openings were observed on both the outer and inner tubing near the break location.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing.No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion.Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils.

Manufacturer Narrative

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

Event Description

An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to near end of service and lead discontinuity.Follow-up revealed that the procedure was originally scheduled for only generator replacement due to near end of service.Diagnostic results showed lead impedance within normal limits prior to surgery and high impedance was first observed during the procedure.The surgeon elected the replace the patient¿s lead and stated that the explanted lead was kinked.The explanted generator and lead have not been returned to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

The explanted lead was received for analysis.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: 4077034
• MDR Text Key: 5248598
• Report Number: 1644487-2014-02291
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Model Number: 302-20
• Device Lot Number: 201126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2009
• 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: 20 YR