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

Model Number 304-20

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/01/2012

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2013 note that the patient has lumps along the vagal nerve stimulator.The notes indicate that the lumps are the tie downs that secure the strain relief.It was noted that the patient's mother indicated that since the patient was hit in the neck with a ball that the tie downs have been more prominent.The mother indicated that the patient's previous physician performed diagnostics after the patient was hit in the neck with the ball and that diagnostics were within normal limits.The notes indicate that the patient will be referred for surgery to have the tie downs removed to prevent possible erosion through the patient's skin resulting in an infection.The notes indicate that the tie downs are painful to the touch and are nearly at the point of breaking through the skin.The notes indicate that the tie downs have definitely migrated and are protruding out through the skin.The patient was scheduled for surgical revision of the tie downs.

Event Description

On (b)(6) 2014 it was confirmed that the patient underwent surgery on (b)(6) 2013 to remove the two lead tie-downs.Per the op-notes received, the pre-op diagnosis was that the two tie-down tabs were protruding into the skin with thinning of the skin over the tie-down tabs and concern for skin erosion.It was noted that the patient was hit in the neck by a ball recently and when this happened, these tie-down tabs became more prominent.The surgeon stated that the patient has very thin skin and the tie-down tabs were protruding through the neck and can be seen under the skin to the point where you can almost see the fact that they were white.There was no evidence of skin breakdown or infection during surgery.Diagnostics were performed before and after the removal of the tie-downs confirming lead impedance within normal limits.During removal of one of the tie-downs, scar tissue was removed as well from around the tie-down.

• 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: 3632097
• MDR Text Key: 4178372
• Report Number: 1644487-2014-00445
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2014
• Device Model Number: 304-20
• Device Lot Number: 2815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2010
• 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: 4 YR