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

Model Number 304-20

Device Problem Electro-Static Discharge (2149)

Patient Problems Pain (1994); Swelling (2091); Electric Shock (2554)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

The explanted lead has been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned lead portion was completed and confirmed an opening of inner tubing which exposed the conductive quadfilar coils.Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the exposed surface and show what appears to be wear (smoothed surfaces) at the exposed portion.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description

It was reported on (b)(6) 2015 that the patient is currently unhappy with the placement of the device.The physician referred the patient for a second opinion.

Manufacturer Narrative

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

Event Description

Initially, it was reported that the patient experienced swelling and pain over the generator site.The patient was given antibiotics and the swelling resolved.It was reported that the patient was still experiencing pain at the generator site.The patient was seen for follow-up and it was reported that there was no infection and the patient was doing better.It was later reported that the patient was being shocked by the vns and that the device was interrogated and there were no problems.It was reported that the physician thought the patient's body may not be tolerating vns.It was reported that the patient wanted the device removed.It was later reported that the patient was experiencing shocks in his jaw and left arm and that the device was programmed off and the shocking resolved.It was reported that the patient would be scheduled for surgery to explore the lead.The patient's parents want the device explanted if nothing is found to resolve this shocking.The patient underwent lead replacement due to the increased discomfort over the last three months.The surgeon believed that the lead insulation directly under one of the tie-downs was worn away.The surgeon believes that the tie-down caused damage to the lead.It was later reported that the surgeon identified a break in the lead near the vagus nerve.It was reported that the patient's symptoms have completely resolved with lead replacement.The lead is expected to be returned for analysis, but has not been received to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

• Brand Name: LEAD MODEL 304
• 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: 4128664
• MDR Text Key: 4969784
• Report Number: 1644487-2014-02512
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2014

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: 04/30/2016
• Device Model Number: 304-20
• Device Lot Number: 3305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 09/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/03/2014; 12/05/2014; 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2012
• 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: 15 YR