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

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291); Device Inoperable (1663)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

Analysis of the generator was completed on (b)(4) 2014.The generator performed according to functional specifications.During the product analysis there were no anomalies found with the pulse generator.Analysis of the lead was completed on (b)(4) 2014.An abraded opening was noted at the end of the silicone tubing of the positive coil.A break was identified at the ends of the positive and the negative lead coils.Scanning electron microscopy images of the positive and the negative coil show that pitting or electro-etching conditions have occurred at the broken ends.However, due to metal dissolution and surface contamination the fracture mechanism cannot be determined.

Manufacturer Narrative

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

Event Description

It was reported by the neurologist that vns patient¿s diagnostic results revealed high lead impedance (dc dc = 7) so the generator was programmed off.Clinic notes were received for the patient¿s office visit with her neurologist on (b)(6) 2014.The notes indicate that the patient¿s condition is deteriorating.The notes also indicate that magnet stimulation was no longer effective in aborting the patient¿s seizures.Additional information was received stating that patient manipulation or trauma is not believed to have caused or contributed to the high impedance.X-rays were taken and lead discontinuity was found.The patient underwent generator and lead replacement surgery for lead discontinuity on (b)(6) 2014.During the procedure, the surgeon observed a lead fracture near the sternocleidomastoid.The surgeon stated that the anchor tether was missing from the lead and that he could not find any tie downs on the explanted lead.Review of the available programming and diagnostic history showed normal diagnostic results through 2009.The explanted generator and lead were returned to the manufacturer on (b)(4) 2014 and analysis is currently underway.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records for the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

• 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: 3667817
• MDR Text Key: 4274360
• Report Number: 1644487-2014-00628
• 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
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2007
• 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: 11 YR