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 Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that a patient's generator and lead were explanted due to infection and wound breakdown with no immediate replacement.Further clarification was received that the infection was at the vns generator site and the wound had stated to dehisce.The explanted devices were returned.It was further stated that the patient had been in-patient for 4 days with glucose readings of over 400 mg/dl every night.The surgeon stated that the glucose being uncontrolled was a contributing factor to the infection.Device history records were reviewed for the implanted devices and were noted to have been sterilized and passed all quality inspections prior to distribution.No additional relevant information was 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8241440
• MDR Text Key: 132846811
• Report Number: 1644487-2019-00049
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2020
• Device Model Number: 106
• Device Lot Number: 5710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Event Location: Other
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2018
• 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: 9 YR