MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Unspecified Infection (1930)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? - device evaluation is not necessary because the reported event is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that a patient was scheduled for explant due to wound infection.The device history records were reviewed for the generator and the lead and revealed that both devices met sterility specifications prior to release.No additional relevant information has been provided to date.No known surgical intervention has occurred to date.

Event Description

The patient initially presented with a stitch abscess at his generator site one month after implant surgery.Three months later, the patient presented with a surgical wound infection at the generator incision site.The patient's surgeon believed that the patient picking at the incision sites caused the abscess and infection.Both the patient's lead and generator were explanted after the infection appeared.No additional relevant information has been provided to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6567728
• MDR Text Key: 75185545
• Report Number: 1644487-2017-03803
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2017
• Device Model Number: 106
• Device Lot Number: 203844
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2016
• 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