MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GENERATOR MODEL 106

Model Number 106

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

Patient Problem Unspecified Infection (1930)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

Event Description

It was initially reported that the patient was scheduled for a vns generator replacement less than two months after initial implant.The reason for the replacement was not report at first.Further follow-up found that the patient's generator had been explanted a few weeks following implant after the patient's parents noticed swelling at the generator site.It was later confirmed that the generator site was infected.When the generator was explanted the vns lead was left implanted.The patient was treated with antibiotics via iv and oral medication.Manufacturing records confirmed that the generator was sterilized prior to distribution.No additional relevant information has been received to date.

• Brand Name: PULSE GENERATOR 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: 7311871
• MDR Text Key: 101460824
• Report Number: 1644487-2018-00327
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2019
• Device Model Number: 106
• Device Lot Number: 204201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2017
• 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: 5 YR