MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Syncope (1610); Arrhythmia (1721); Dyspnea (1816)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via social media comment on a forum post that the patient experienced bradycardia six days following implant, two weeks following that, and several years after that.The patient reported passing out, shortness of breath, and not being able to stay awake.Her heart rate was stated to be in the 20s and while in the hospital, she had to disable the vns using the magnet.The patient stated that when the vns stimulated every five minutes, her heart rate would drop.With the magnet disablement, she stated that her heart rate return to normal.The patient was worried about getting the vns removed as it had been working for her seizures.The patient had a pacemaker recently implanted.It was previously reported that the patient experienced fainting and dizziness that the medical professional attributed to very high doses of the patient's medications, which resolved when the patient stopped taking the high doses.No additional relevant information has been received to date.

Event Description

Follow up with the physician's office revealed that the patient's bradycardia occurring six days after implant and two weeks following that was caused by medications.The physician was unable to provide any information about the more recent events as the patient was no longer seen by the office.

• Brand Name: PULSE GEN MODEL 102
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7468305
• MDR Text Key: 106730085
• Report Number: 1644487-2018-00673
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 102
• Device Lot Number: 202816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• 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; Other
• Patient Age: 41 YR