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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device showed high impedance and was disabled.Clinic notes were received indicating that the patient was experiencing an increase in seizures.The patient underwent generator and lead replacement surgery on (b)(6) 2014.The explanted devices have not been returned to date.

Manufacturer Narrative

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

Event Description

Analysis of the returned generator and lead was completed.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Lead discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions.The condition of the lead suggests that patient manipulation caused the lead discontinuity.The inner silicone tubing of the negative coil has what appears to be a punctured opening.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions.Scanning electron microscopy images of the positive coil at the end of the first portion of the lead and the strand segments identified in the vicinity of the positive coil show that pitting or electro-etching conditions occurred on the coil wires.

Event Description

The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.The reason for explant was listed as patient self-abuse.

• Brand Name: LEAD MODEL 304
• 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: 4301752
• MDR Text Key: 5058842
• Report Number: 1644487-2014-03228
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Model Number: 304-20
• Device Lot Number: 2762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 27 YR