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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Staphylococcus Aureus (2058)

Event Date 12/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient who is subject to a vns study had a postoperative surgical wound infection at the left side of patient's neck.The event started on (b)(6) 2016.The affected site was painful to touch with local redness.It was reported that the event was related to vns surgery.The patient was hospitalized due to that infection and an emergency exploration was performed.It was reported that the cause of that infection was staphylococcus epidermidis.It was reported that the entire vns system was explanted on (b)(6) 2016.No device malfunction was reported.The issue was resolved with no sequelae and the patient was discharged from the hospital feeling well and in clinically stable condition.Both explanted lead and generator were returned to the manufacturer on 02/15/2016.Analysis is underway but it has not been completed to date.Review of manufacturing records confirmed that both, the lead and generator were sterilized prior to distribution.

Manufacturer Narrative

Brand name; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.Type of device, name; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.Model number, serial number, lot number, expiration date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.Device manufacture date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.Additional manufacturer narrative and/or corrected data, corrected data: the previously submitted mdr inadvertently provided the wrong udi number.No udi number available for the suspect device.

Event Description

The patient was implanted on (b)(6) 2015 and the infection was diagnosed on (b)(6) 2016.Analysis of the returned lead was completed.It indicates that other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.Analysis of the returned generator was completed.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the product analysis laboratory, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 1.071% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 5440693
• MDR Text Key: 38302637
• Report Number: 1644487-2016-00326
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2013
• 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: 42 YR