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); Local Reaction (2035); Tissue Breakdown (2681)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

Event Description

It was reported that the patient's vns lead wire was extruding from his neck.The physicians wanted to explant the device as a result.Follow up by the tc revealed that there was no trauma or patient manipulation that could have contributed to the event.The physician's office believed that the patient was allergic to the vicryl sutures placed after surgery as the patient has been in almost weekly since the date of implant due to his body rejecting the sutures and pushing them out of his skin.It was stated that this caused abscess type problems around the generator and neck and that the patient has been back in previously to remove the sutures and clean the surgery site.It was later reported that the patient responded well to vns therapy, but had significant swelling around the generator and approximately 2 inches of the lead was protruding.The surgeon decided to explant the whole vns system and give the patient time to recover from the infection.A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution.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: 7877560
• MDR Text Key: 120303254
• Report Number: 1644487-2018-01617
• 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: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2020
• Device Model Number: 106
• Device Lot Number: 204365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2018
• 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: 38 YR