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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device showed high impedance.The patient had also been experiencing an increase in seizures.The patient was sent for x-rays and referred for surgery.No known surgical interventions have occurred to date.

Event Description

An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015.The explanted devices have not been returned to date.

Event Description

The explanted generator and lead were returned to the manufacturer for analysis which confirmed discontinuity of negative quadfilar coil in the body region of the returned lead portion.Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting.Pitting was observed on the coil surface.Abraded openings of both outer and inner tubing were observed near the break location.The abraded opening and tear found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.There were no performance or any other type of adverse conditions found with the pulse generator.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Manufacturer Narrative

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

Manufacturer Narrative

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

• 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: 4410130
• MDR Text Key: 5437783
• Report Number: 1644487-2015-03596
• 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: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2005
• 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: 60 YR