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

Model Number 103

Device Problems Use of Incorrect Control/Treatment Settings (1126); Self-Activation or Keying (1557)

Patient Problems Chest Pain (1776); Pain (1994)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

Additional information was received that the patient's vns device was programmed by a different physician on (b)(6) 2015 to the settings observed on (b)(6) 2015.It was noted that the pulse width had been decreased from 250 to 130.

Event Description

It was reported that the patient experienced pain and chest discomfort with vns stimulation when magnet was swiped.Interrogation of the generator showed that the patient¿s magnet mode output current was set higher (3.0 ma) than what was previously programmed (2.75 ma).The pulse width and the normal mode on time were also changed.The physician questioned about the possibility of vns settings automatically changed without the physician programming the device.The patient also mentioned that no other physician changed the vns settings.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4702201
• MDR Text Key: 5775185
• Report Number: 1644487-2015-04491
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2015
• Device Model Number: 103
• Device Lot Number: 3636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2013
• 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 Age: 16 YR