MAUDE Adverse Event Report: CYBERONICS, INC. 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); Chest Pain (1776); Pain (1994)

Event Date 06/07/2017

Event Type  Injury  

Event Description

A patient was admitted to the hospital after experiencing sinus bradycardia, tachycardia, and syncope.The patient's family doctor, who did not manage the patient's vns, did not believe that the arrhythmias and syncope were related to vns; however, the medical staff at the admitting hospital wanted to monitor the patient to understand whether there was a relationship between the arrhythmias and syncope to vns.Both the medical staff and family doctor believed that the syncope was potentially related to the bradycardia as it occurred when the position rose to a standing position after sitting down.Monitoring determined that the patient's bradycardia was constant during both vns stimulation on and off times.According to the nurse at the admitting hospital, the patient had previously been admitted to another hospital for nonsustained ventricular tachycardia three years prior to the recent arrhythmias.The patient's resting heart rate was reportedly 54 beats per minute.Device diagnostics were performed and returned results within the normal limits.Additionally, the patient reported that her vns settings had not been changed by her prescribing psychiatrist in over 5 years.The attending nurse later reported that she believed that the patient's blood pressure medication was adjusted during the hospital, but she did not know of the cause of the arrhythmias and syncope or their relation to vns.No further relevant information has been provided to date.

Event Description

Clinic notes were received from the patient's er visit that indicated that the patient was admitted to the hospital after experiencing cardiac-related chest pain that was unrelieved by nitroglycerin.The patient's resting heart rate on intake was 51 beats per minute, and her blood pressure was 104/70, which was indicated as within the normal limits.The chest pain radiated to the patient's left arm and shoulder.The patient was noted to be bradycardic.X-rays taken on the day of admission showed cardiomegaly, but there was no evidence of that condition observed in x-rays the following day.Per the clinic notes, the vns was interrogated and observed to be at neos = no with diagnostic results within the normal limits.The vns was disabled via magnet inhibition while the medical staff attempted to discern the relation of the vns to the patient's bradycardia.The medical staff later assessed that the chest and left arm pain were caused by the patient's beta blockers.The patient's medications were adjusted several times during the hospital stay.The chest pain appeared to resolve after a change to new medication, and the patient was discharged from the hospital in stable condition.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6685193
• MDR Text Key: 79024615
• Report Number: 1644487-2017-04086
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

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: 09/30/2007
• Device Model Number: 102
• Device Lot Number: 014188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/03/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2005
• 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; Life Threatening
• Patient Age: 53 YR