MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Tachycardia (2095); Syncope/Fainting (4411); Unspecified Respiratory Problem (4464)

Event Date 12/04/2022

Event Type  Injury  

Event Description

It was reported that patient had several seizures and his mother swiped the magnet and brought him to the emergency room.In the emergency room, patient had sinus tachycardia.The event was isolated but during the course of care, he presented an episode of extreme bradycardia with loss of consciousness, respiratory arrest and cardiac massage and resumption of a sinus rhythm after three cuts of asystole.The patient woke up with normal consciousness.He presented a few minutes later a new episode with a heart rate from 115 to 50 in 1 minute with loss of knowledge and respiratory arrest.The stimulation of the patient allowed a resumption of breathing and a revival of the heart rate.The patient was then treated in the continuing care unit.The patient's vns was then turned off.Patient did not faint again.A tilt test will soon be carried out to find out if there is a autonomic vagal hypertonia that increased with vns stimulation.Physician reported that patient does not have a prior history or family history of cardiac events.The patient does have pre-existing medical conditions, but they are not important except epilepsy.The patient experienced tachycardia and asystole.The patient also experienced palpitations and syncope.The events did not occur following a medication change.The patient had seizures and arrived to the emergency room.The events did not occur while performing diagnostics, nor following a settings change.An eeg was used to diagnose the arrhythmia.The physician does not know if the arrhythmia is related to vns stimulation.She does believe the vns exacerbated or co-currently contributed to the arrhythmia in the form of vagal hypertony.Intervention was taken in the form of little cardiac massage.The generator was programmed on at the time of arrhythmia but the arrhythmia has not recurred.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.(b)(4).

• Brand Name: PULSE GEN MODEL 1000
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16064932
• MDR Text Key: 306317478
• Report Number: 1644487-2022-01668
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2023
• Device Model Number: 1000
• Device Lot Number: 205757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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): Life Threatening; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male