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 Apnea (1720); Bradycardia (1751); Syncope/Fainting (4411)

Event Date 12/30/2022

Event Type  Injury  

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.

Event Description

It was reported that the patient began to experience apnea and vns parameters were reduced.The patient later followed up for the apnea and settings were increased.Since the follow-up, the patient was admitted to the hospital due to heart valve blockage and vns parameters were reduced; the physicians later proposed implanting a pacemaker.Prior to the pacemaker implant, the vns was disabled and patient was monitored.During stimulation the patient's heart rate (hr) was seen at 120 bpm and with the vns disabled the hr dropped to 90 bpm.Session reports were provided and diagnostics were all seen within normal visits.Update was received that the vns remains off and the hr has dropped from 120 bpm to 80 - 100 bmp.The physicians suspect that the high dosage from the vns could be the cause from the event.The vns will remain off and patient will have a pacemaker implanted.The plan is to increase the output to 0.25 ma and monitor the patient.Response was received from the physician.The physician noted that the patient presented with syncope initially and had no history of cardiac events.The hr prior to event was 80-120 bpm and the hr during event 0-30 bpm.Per the physician, the arrhythmia was possibly related to the vns.The patient also had a pacemaker implanted and has experienced no arrhythmia since the implant.No other relevant information has been received to date.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 19197190
• MDR Text Key: 341199031
• Report Number: 1644487-2024-00479
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2023
• Device Model Number: 1000
• Device Lot Number: 205668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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): Hospitalization