MAUDE Adverse Event Report: CYBERONICS, INC. PULSE 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); Inflammation (1932); Swelling (2091)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that four weeks post initial vns lead and generator implant there was swelling at the vns site which suggested the presence of an infection.There was no active discharge however the incision appeared inflamed.It was unclear if this was the lead incision or generator incision.The patient was admitted to the hospital for 10 days and placed on an iv of antibiotics and after a few days the swelling had gone down.The patient was then released and sent home with a picc.However about a week later the infection had not resolved and pus was discharging from the incision.The patient was then readmitted to the hospital and referred for explant surgery due to the infection.It was reported that surgery was postponed due to the infection not getting under control.No surgical interventions are known to have occurred to date.The manufacturing records of the lead and generator were reviewed and indicated that both were sterilized prior to distribution.No additional relevant information has been received to date.

Event Description

It was reported that the infection was occurring at the generator incision site however the swelling appeared to improve overnight.The physician did not suspect that patient manipulation or trauma contributed to the infection.The physician reported that the explant surgery was canceled due to the swelling spontaneously resolving and the lab results greatly improving.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: 5924653
• MDR Text Key: 53813488
• Report Number: 1644487-2016-01983
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 106
• Device Lot Number: 203655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 14 YR