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

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient had experienced wound dehiscence at the electrode incision site due to manipulation.The patient received medical intervention.The area was drained and a new suture was performed.The physician did not see any evidence of an infection, but did prescribe antibiotics.The physician believed that the patient's caregiver applied pressure to the incision during bathing, which caused the wound to open.

Event Description

It was reported that the physician performed drainage of an abscess on (b)(6) 2015.He then decided to remove the entire vns system due to infection with secretion at the generator site.The patient was not hospitalized for this procedure.The cause of the infection was probably due to the mother of the patient cleaning the incision site roughly with some contaminated product or bacteria on the skin.The infection was located at both the generator and incision sites.No culture results were available, but the physician indicated that there were signs of infection.A review of the device history records showed that the generator and lead were sterilized prior to release.

• 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: 5059042
• MDR Text Key: 25106200
• Report Number: 1644487-2015-05452
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/23/2018
• Device Model Number: 304-20
• Device Lot Number: 203179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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: 14 YR