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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 09/01/2015

Event Type  malfunction  

Event Description

It was reported by a company representative that high impedance was found upon interrogation at a clinic visit.The device was not disabled, but x-rays were ordered.X-rays have not been received by the manufacturer for review to-date.It was reported the patient was not experiencing any noticeable pain, but the patient is non-communicative.It was reported that the patient used to do well with the vns but had a significant increase in seizures in the prior month.No known trauma or accidents had occurred.The generator and lead were replaced on (b)(6) 2016.The generator was replaced prophylactically.The explanted devices were received for analysis which is underway, but has not been completed to-date.Later follow-up to the physician's office revealed that the increase in seizures began approximately 4 months prior.The high impedance was found on (b)(6) 2016, and the patient had not been seen at the clinic for almost a year.The increase in seizures was attributed to the onset of high impedance.The lead was reported to have been "cracked".Additional follow-up from the tc on (b)(6) 2016 revealed that the physician also found fluid in the lead at surgery.No additional relevant information has been received to-date.

Event Description

Analysis was completed for the returned generator.The data downloaded from the generator shows an indication of increased impedance.The last > 25% change in impedance was on (b)(6) 2016 with an initial value of 6682 ohms and a final value of 4868 ohms (explanted (b)(6) 2016).The device output signal was monitored and results showed no signs of variation in the pulse generator's output signal.The device provided the expected level of output current for the entire monitoring period.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.Analysis was completed for the returned lead.A coil break was identified in the negative coil.Abraded openings were noted on the outer silicone tubing and the inner silicone tubing of the negative coil.Scanning electron microscopy images of the negative lead coil show that pitting or electro-etching conditions have occurred at the break locations.Scanning electron microscopy images of the negative coil show appearance suggesting that fatigue stress induced fracture has occurred in at least two strands of the quadfilar coil.Due to metal dissolution, surface contamination and/or mechanical distortion the fracture mechanism of other strands could not be ascertained.Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 5404263
• MDR Text Key: 37741311
• Report Number: 1644487-2016-00202
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

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: 01/31/2005
• Device Model Number: 302-20
• Device Lot Number: 7631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2003
• 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