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 Unspecified Infection (1930); Scarring (2061)

Event Date 07/19/2017

Event Type  Injury  

Event Description

It was reported that a vns patient developed an infection at the implant site after the device was turned on.The device was turned off and the generator was relocated and the patient was treated with antibiotics.On (b)(6) 2017 the device was turned on again.It was provided there is evidence of a form of keloid, and the electrodes appear exposed.Washing and antibiotics were prescribed.The patient was hospitalized and treated with antibiotics and was receiving continuous washing at the electrode.Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution.Additional relevant information has not been received to-date.

Event Description

Follow-up from the distributor provided that the device was explanted.The explanted devices have not been received by the manufacturer to-date.

Event Description

The explanted generator was received on 01/31/2018.Analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed for the returned generator.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 6996660
• MDR Text Key: 90882406
• Report Number: 1644487-2017-04720
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2019
• Device Model Number: 106
• Device Lot Number: 5183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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: 9 YR