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

Model Number 304-20

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2014

Event Type  Injury  

Event Description

Additional information was received stating that the vns patient has not been re-implanted to date.

Event Description

It was reported that the generator and lead were explanted and that the patient will be reimplanted in about two weeks.It was reported that there was some concern about the patient developing an infection.The patient was placed on antibiotics.

Event Description

The physician reported that there is a "5 mm open area that appears to be a wire" on the patient's neck.The patient's brother was observing the patient and stated that he believed the patient rubbed the area and created the opening.The patient had a consult for surgery on (b)(6) 2014.System diagnostics were normal.The surgeon attributes the exposure to patient manipulation.No medication or treatment changes preceded the issue.The family was not aware when the issue started.The patient has been referred for surgery.Surgery is likely, but has not occurred to date.

Event Description

The patient underwent generator and lead reimplant.

• 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: 3595152
• MDR Text Key: 4223057
• Report Number: 1644487-2014-00312
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2014

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: 06/30/2016
• Device Model Number: 304-20
• Device Lot Number: 3348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 01/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2014; 04/09/2014; 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2012
• 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): Other
• Patient Age: 48 YR