MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

Patient Problem Seizures (2063)

Event Date 11/06/2015

Event Type  malfunction  

Event Description

Patient was referred for possible generator and lead revision surgery.Notes received for the referral indicates that patient had complete fracture in one of his leads in (b)(6) 2015.Patient had increased frequency of seizures throughout the day as a result.No additional relevant information has occurred to date.No known surgical interventions have occurred to date.

Event Description

The surgeon later reported that the patient's vns was suspected to be not working and x-rays were ordered.The lead fracture was suspected based on these events.No diagnostics were performed by the surgeon to confirm high or low impedance.No additional relevant information has been received.No known surgical interventions have occurred to date.

Event Description

It was reported that the surgeon noticed at replacement surgery that the lead felt bunched up at the neck incision site under the skin.After the incision was opened, the lead was found to be twisted and there wasn't proper strain relief.Reportedly the lead was broken in half.They didn't have evidence of patient manipulation; however, the patient did have intellectual disabilities and roughhoused with his sponsor, who would wrestle with him.The lead and generator were replaced due to high impedance.The suspect product has not been received to date.No further relevant information has been received to date.

Event Description

It was reported that the lead appears to be disconnected from the generator per x-ray images.It is unclear if there is a lead fracture or lead pin disconnection.

Event Description

Product analysis was completed on the returned lead on (b)(4) 2018.The lead was returned in 3 pieces.Portions of the lead, including the electrodes, were not returned.Multiple abraded openings were noted in the outer and the inner silicone tubing of the second and third portion of the returned lead, and the lead assembly had 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 portions.At least one of the lead coils were protruding from the lead at the abraded openings.The outer silicone tubing had a twisted and compressed appearance at multiple locations.The lead was also kinked at multiple locations.The overall appearance of the lead is consistent with patient manipulation of the implanted device, a ¿twiddler¿.A lead fracture was verified.Scanning electron microscopy images of the lead coils at the first portion of the returned lead show that pitting or electro-etching conditions have occurred at the end of the coils.The negative coil shows appearance suggesting that a stress-induced fracture (due to rotational forces) has occurred on the coil.However, due to metal dissolution the fracture mechanism of the positive coil cannot be ascertained.Scanning electron microscopy images of the lead coils at the second portion of the returned lead (positive and negative) show appearance suggesting that a stress-induced fracture (due to rotational forces) has occurred on the coils.Also, secondary stress fractures and stress fissures were noted in the vicinity of the coil breaks.Note that since a portion of the lead (including the electrode array) 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 portions.

Event Description

The explanted generator and lead were received for product analysis.Product analysis was completed on the returned 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.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications with no anomalies identified.Product analysis on the lead is underway but has not been completed to date.

• Brand Name: LEAD MODEL 304
• 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: 6822711
• MDR Text Key: 83732592
• Report Number: 1644487-2017-04380
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Model Number: 304-20
• Device Lot Number: 201868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• 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): Other
• Patient Age: 15 YR