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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Fibrosis (3167)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

High impedance was observed during diagnostics tests performed around (b)(6) 2015.Patient also experienced increased seizure at that time.Patient underwent lead replacement on (b)(6) 2015 and the explanted lead was returned on (b)(6) 2015.During surgery, fibrosis was observed and was surgically removed in order for the new lead to be placed.Additional information was received that the high impedance was first noted on (b)(6) 2015 initially when the physician performed normal mode diagnostic test after increasing the output current to 0.75 ma.The results indicated dcdc=7 and high lead impedance.Lead pin insertions issue was tested and was ruled out as the issue.Good diagnostics and normal impedance was observed for this patient after implant prior to high impedance.Patient's seizures was reported to have increased since (b)(6) 2015.The relation to pre-vns baseline is unknown at this time.Patient manipulation or trauma is not believed to have contributed to the high impedance.Analysis of the lead is underway but has not been completed.

Event Description

An analysis was performed on the returned lead portions.A portion of the lead was not returned to the manufacturer and therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the lead, the quadfilar coil appeared to be broken at the proximal end of the anchor tether.Analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.An abraded opening was found on the outer silicone tubing.No other obvious anomalies were noted.

Manufacturer Narrative

Device failure occurred, 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: 4596345
• MDR Text Key: 5466958
• Report Number: 1644487-2015-04121
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 302-20
• Device Lot Number: 202399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 03/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2013
• 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: 8 YR