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

Model Number 103

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problems Pain (1994); No Information (3190)

Event Date 10/19/2016

Event Type  Injury  

Event Description

A call was received from a physician stating that a patient was reporting that their lead neck site was "heating up" and the vns was causing pain at the chest wall.The patient was also experiencing jaw pain which stimulation, and her heart slowed down when the vns was stimulating.The patient stated that she was supposed to receive stimulation every 5 minutes but she was feeling the device go off every 30 seconds.A review of the available programming history showed that the patient's settings from (b)(6) 2012 had a 5 minute off time.The physician was told to use a magnet to inhibit stimulation for the patient.No further relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

A patient alleged that vns almost killed her, stating that it electrocuted her vagus nerve and the connected organs.The patient believed that her vns malfunctioned and contributed to years of pain and damage, leading her to have the device explanted 1 month prior to her report; however, no device malfunction has been identified to date.A review of programming history for the patient's device available from the date of implant through the next 2.5 years indicated that the device functioned properly throughout the available history.The programming history indicated that the device was programmed off in march 2015.A physician who followed the patient in 2016 indicated that the device was programmed on in february, and programmed off again in october.The physician could not assess the cause of the patient's reported adverse events since the physician had only seen her twice in his clinic.No additional relevant 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: 6096084
• MDR Text Key: 59770721
• Report Number: 1644487-2016-02610
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2018

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: 04/30/2014
• Device Model Number: 103
• Device Lot Number: 202128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: 11/30/2017; 01/04/2018
• Supplement Dates FDA Received: 12/22/2017; 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2012
• 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): Hospitalization
• Patient Age: 40 YR