MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/01/2014

Event Type  Injury  

Event Description

It was reported that the vns patient underwent surgery to explant her device on (b)(6) 2015 due to painful stimulation.Attempts for additional relevant information have been unsuccessful to date.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

Information was received indicating that the patient¿s device was explanted on (b)(6) 2015 due to pain.The pain was first observed in (b)(6) 2014 in the throat and at the electrode site.The physician decided to disable the device in (b)(6) 2014 for patient comfort.The physician later attempted to program the patient¿s device back on and the patient was unable to tolerate the minimal device settings.The patient reported a burning sensation at the site of implantation, which recurred every five minutes during stimulation on-times.She also complained of dysphonia and tension of the platysma muscle.The patient¿s seizure frequency remained the same.Mri was performed with the purpose of finding an epileptogenic lesion (which was actually found in that study).It was indicated that programming changes/ medication changes/ other external factors did not cause or contribute to the pain.The patient had no prior history of this particular pain prior to vns.Product analysis was completed for the generator.There were no performance or any other type of adverse conditions found with the generator.Product analysis was completed for the lead.Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Manufacturer Narrative

Patient age; corrected data: the previously submitted mdr inadvertently provided an incorrect patient age.Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date.Event description; corrected data: the previously submitted mdr inadvertently did not include all of the information available regarding the event.Date of explant; corrected data: the previously submitted mdr inadvertently provided the wrong explant date of the device.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4577017
• MDR Text Key: 5558085
• Report Number: 1644487-2015-04069
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Model Number: 103
• Device Lot Number: 202565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• 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: 51 YR