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

Model Number 304-20

Device Problems Mechanical Problem (1384); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During implant surgery for the patient¿s lead, it was noticed that after the lead had been tunneled a deformity on the electrode was observed.The surgeon was able to connect the anchor and positive electrode with no issues, but when connecting the negative electrode he stated it appeared bent, and he didn¿t think it would attach to the nerve properly.There was no abnormality observed with the lead prior to the lead being removed from the packaging.It is unclear how the deformity occurred.The deformed lead was returned for product analysis which has not been completed to date.The design history record for the lead was reviewed and showed that the lead passed all quality control checks prior to being released for distribution.

Event Description

Product analysis for the lead was completed and found that the negative electrode ribbon did appear to be detached from the silicone helix, which has lost its helical shape.There were also creases present on the positive and negative electrodes along with remnants of dried body fluid.These finding are consistent with damage incurred during implant/explant surgeries.

• 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: 6138374
• MDR Text Key: 61592457
• Report Number: 1644487-2016-02746
• 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: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2020
• Device Model Number: 304-20
• Device Lot Number: 300387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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: 20 YR