MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 08/13/2014

Event Type  Injury  

Event Description

It was reported that the vns patient was experiencing pain and possibly developed an infection at lead incision site.No further information has been received to date.

Event Description

It was identified that a duplicate report of this patient's infection was submitted in mfg report #: 1644487-2014-02448.This report will house any future information related to the infection.It was reported that the infection may have been related to the sutures from surgery, although surgery was over a year prior.

Manufacturer Narrative

Suspect medical device, corrected data: the initial report inadvertently reported the incorrect suspect device.Device manufacture date, corrected data: the initial report inadvertently reported the incorrect suspect device.Evaluation codes, corrected data: the initial report inadvertently did not report the device history records being reviewed and report the results and conclusion codes incorrectly.Manufacturer device history records were reviewed.A review of device history records showed that the lead met specifications for sterilization testing prior to distribution.

• Brand Name: LEAD MODEL 303
• 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: 4113036
• MDR Text Key: 4840517
• Report Number: 1644487-2014-02440
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 303-20
• Device Lot Number: 202132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2012
• 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): Other
• Patient Age: 52 YR