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

Model Number 304-20

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Staphylococcus Aureus (2058)

Event Date 07/29/2014

Event Type  Injury  

Event Description

It was reported that the vns patient¿s neck incision site dehisced and exposed the lead on (b)(6) 2014.The patient underwent surgery on (b)(6) 2014 to close the incision site and no signs of infection were observed at the time.On (b)(6) 2014, the patient presented with a small amount of pus from the incision site and was subsequently treated with an antibiotic regiment.Cultures were positive for staph aureus.It was noted that the patient did not take proper care of her incision sites and was noncompliant in keeping her appointments.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description

It was reported on 01/19/2015 that the patient¿s lead and generator were explanted on (b)(6) 2015 due to infection.The patient was not re-implanted at this time.The lead and generator were returned for analysis on 01/21/2015.Product analysis was completed for the lead on 02/09/2015.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Product analysis was completed and approved for the generator on 02/17/2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.034 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.

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: 4353667
• MDR Text Key: 5173243
• Report Number: 1644487-2014-03445
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/19/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• 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): Required Intervention
• Patient Age: 34 YR