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

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2014

Event Type  Injury  

Event Description

It was reported that the patient presented with an infection at the electrode site.The patient was admitted for explant of the vns system.The patient was prescribed antibiotics.It was reported that the infection was a result of vns implantation.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Event Description

It was reported that the patient underwent generator and lead explant due to the infection.No reimplant is planned.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

• 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: 3672262
• MDR Text Key: 4241807
• Report Number: 1644487-2014-00652
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: 304-20
• Device Lot Number: 3729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR