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

Model Number 106

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

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

Code 81 - device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.

Event Description

It was reported that a patient was scheduled for a possible full revision due to a lead extrusion.Further updates indicated that the patient had an infection.The patient had stated that after a big seizure, he saw a blue cord showing through his left chest wall.The hole was stated to be the size of a dime at the vns generator incision site.Follow up with the surgeon's office stated that the patient had not been seen since the implant and that he was scheduled for a planned explant, leaving the leads implanted, on 07/23.They had heard the report of extrusion from the patient's girlfriend and assumed that the site was likely infected by now as the patient has had an open wound at his chest incision site.The surgeon's current assumption, based on the call received from the girlfriend, was that the wound opened and the lead was extruding due to a bad seizure that took place.An additional follow up from the surgeon stated that he believed the infection was due to the difficulties that occurred during the implant surgery in which incision sites were reopened for troubleshooting, thereby increasing risk of infection.Explant of the generator was confirmed to have occurred and it was stated that the patient remained in the hospital post-operation for iv antibiotics.The physician confirmed that the extrusion was related to the infection and body's rejection of the device.The infection was confirmed to be in the neck and chest and was determined to be possibly related to surgery.No additional relevant information has been received to date.

• Brand Name: PULSE 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: 7774054
• MDR Text Key: 116801854
• Report Number: 1644487-2018-01373
• 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: 08/10/2018

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: Lay User/Patient
• Device Expiration Date: 01/29/2020
• Device Model Number: 106
• Device Lot Number: 204371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2018
• 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: 26 YR