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

Model Number 103

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient's chest incision had opened up and went to the emergency room.The neurosurgeon on duty provided antibiotics and applied several stitches to close the wound.The patient was seen by his surgeon, and it was planned to reposition the generator.The patient's generator and lead were explanted due to infection, and the surgeon believed that the patient had manipulated the device and caused the wound to open and the infection.The device history record of the generator was reviewed, and the device was sterilized prior to release.

Event Description

The physician confirmed that the infection was caused by the patient itching and manipulating the device.The device history record of the lead was reviewed, and the device was confirmed to be sterilized prior to release according to procedure.No further information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 6712521
• MDR Text Key: 80007833
• Report Number: 1644487-2017-04141
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2018
• Device Model Number: 103
• Device Lot Number: 5087
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2016
• 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