MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Chest Pain (1776); Edema (1820); Hemorrhage, Cerebral (1889)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was initially reported in (b)(6) 2018 that the patient was being referred for explant due to pain and swelling.In (b)(6) 2018, it was reported that the patient first reported chest pain about a year prior.It was mentioned that the patient wanted to have their device explanted because they felt that the device was not helping, however the device was disabled earlier that year as the physician stated there had been reduction in the frequency of seizures.In (b)(6) 2018, the surgeon believed that it was highly unlikely that the vns device was causing the pain and swelling, and the neurologist believed that the pain was due to possible fibromyalgia, unrelated to the vns therapy system.The surgeon went on to state that he informed the patient that explanting the generator would not guarantee pain reduction or pain alleviation.However, due to the patient being adamant about explanation, the patient was referred for surgery.Device diagnostics information was not received at this time, however it was mentioned that the patient was at a low setting.The patient later reported, in (b)(6) 2019, that the vns caused jerking, falling, strokes, flushing of the breasts (turned red per patient), and pain throughout the body.The patient also mentioned that the vns caused both their breasts to hurt and turn red, and that both breasts needed to be taken out.Multiple attempts have been made to the physician for an assessment of these allegations, and there relationship to the vns and surgery referral, however no response has been received to date.No known surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8724571
• MDR Text Key: 148915395
• Report Number: 1644487-2019-01191
• 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
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2014
• Device Model Number: 103
• Device Lot Number: 202283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2012
• 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): Required Intervention
• Patient Age: 61 YR