MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK; GENERATOR

Device Problem Extrusion (2934)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Nerve Damage (1979); Paralysis (1997)

Event Type  Injury  

Event Description

A vns presentation was given which included adverse events experienced by vns patients.One event involved a patient with skin necrosis with generator extrusion.One event involved a patient with recurrent laryngeal nerve paralysis.The presentation indicates that (b)(6) of a group of 17019 study patients developed infections.Some of the infection required explant of the device.Attempts for additional relevant information have been unsuccessful to date.This manufacturer report involves the reported skin necrosis event.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 4371455
• MDR Text Key: 5233134
• Report Number: 1644487-2014-03479
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention