MAUDE Adverse Event Report: CYBERONICS - HOUSTON PUSLE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had been picking at her incisions from her vns implant surgery.The incisions were slightly gaping as dehiscence wounds, and dermabond was applied to close the chest and neck incision sites.At the time of the initial report, the patient said that the incisions were healing and closed.There was no redness, oozing, or signs of infection at that time.Further information was received that the patient's neck incision was subsequently oozing pus, and the site was swollen red and painful.The symptoms began on (b)(6) 2016.The patient subsequently followed up with the surgeon's office for an appointment.She was treated with antibiotics to address a superficial infection.It was believed that the infection was also likely caused by patient influence at the surgical site.A review of device history records showed that both the lead and generator were sterilized prior to distribution.No additional pertinent information has been received to date.

• Brand Name: PUSLE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5574698
• MDR Text Key: 42585057
• Report Number: 1644487-2016-00764
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2016

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: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 106
• Device Lot Number: 4661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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: 33 YR