MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Chest Pain (1776); Fall (1848); Complaint, Ill-Defined (2331)

Event Date 04/01/2014

Event Type  Injury  

Event Description

It was reported that the vns patient began experiencing pain in her chest during stimulation on-times after falling into a glass table.The pain resolved when the magnet was used to temporarily disable the device.The device was programmed off during an office visit on (b)(6) 2014.Diagnostic results did not indicate any issues with the patient¿s device.The patient previously reported occasional tightness in her chest, erratic stimulation and stimulation on-times not perceived.The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

Additional information was received that the patient underwent replacement of the generator and lead on (b)(6) 2014.The portion of the lead that was explanted was discarded by the explant facility.The explanted generator was received on (b)(6) 2015.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.During the product analysis, there were no anomalies found with the pulse generator.

• Brand Name: PULSE GEN MODEL 102R
• 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: 4262629
• MDR Text Key: 22003757
• Report Number: 1644487-2014-03081
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2010
• Device Model Number: 102R
• Device Lot Number: 200776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2008
• 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: 47 YR