MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

Model Number 304-20

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that the patient had his vns removed due to the vns electrode breaking through the skin on his left shoulder and subsequent infection.The physician reported that it was interesting that he noticed several weeks prior that the patient was not using his left arm and they could not figure out why, but orthopaedics found no issues with his shoulder.The generator and lead were explanted on (b)(6) 2015 due to infection at both devices sites.It was unknown if there were any external factors that may have contributed to the events.

Manufacturer Narrative

Manufacturer device history records were reviewed.Review of the manufacturer device history records confirmed sterilization was performed 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
• 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: 4504658
• MDR Text Key: 5495238
• Report Number: 1644487-2015-03807
• 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
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 304-20
• Device Lot Number: 202021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2012
• 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): Required Intervention
• Patient Age: 55 YR