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 12/23/2014

Event Type  malfunction  

Event Description

It was reported that the patient was referred for generator and lead replacement due to high impedance.X-rays were taken, but did not reveal any lead discontinuities.It is unknown if any patient manipulation or trauma occurred that may have caused or contributed to the high impedance.No known surgical interventions have been performed to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a 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 lead discontinuity.The explanted devices were returned to the manufacturer for analysis.No abnormal performance or any other type of adverse condition was found with the returned pulse generator.The device performed according to functional specifications.Analysis of the returned lead confirmed discontinuity of positive quadfilar coil in the body region of the returned lead portions.Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the suspected broken end of the coil.However, due to metal dissolution, a conclusive determination of the fracture mechanism of the coil cannot be made.Though it is difficult to state conclusively the most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant.The lead assembly has punctures in the outer silicone tubing and the inner tubing.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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: 4430814
• MDR Text Key: 16629858
• Report Number: 1644487-2015-03663
• 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: 12/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2009
• Device Model Number: 302-20
• Device Lot Number: 200269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2006
• 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: 44 YR