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

Model Number 304-20

Device Problems Melted (1385); Sticking (1597); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

The ent surgeon reported that during implant surgery the surgeon noticed that the negative and positive electrodes were stuck together.It was reported that it appeared as though the electrodeshad melted together.The surgeon was able to pull the electrodes apart and reported that there did not seem to be any visible damage to the lead.Device diagnostics once implanted were within normal limits.This event was previously investigated and concluded to likely be due to a manufacturing operator error and was missed during inspection.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr incorrectly stated that the event was previously investigated and concluded to likely be due to a manufacturing operator error and was missed during inspection.The cause for the event remains unknown, and the device is still implanted in the patient.

• 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: 4038355
• MDR Text Key: 4726050
• Report Number: 1644487-2014-02107
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 304-20
• Device Lot Number: 202968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 08/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/20/2014; 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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: 63 YR