MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problem Syncope (1610)

Event Date 07/01/2018

Event Type  Injury  

Event Description

Clinical notes were received which reported that the patient is able to feel vns stimulation (i.E.¿kick in from time to time), but the patient may still have small seizures and he may faint or pass out.The notes state the vns was interrogated during the vns visit and was found to show end-of-life of the battery.Information was received from the physician¿s nurse that the physician had no had no way to tell what the cause of the fainting was but that the patient appeared to have been doing better after his replacement although the reason for replacement was not due to the fainting.Regarding the relationship of the fainting to vns, the nurse did not directly answer that vns was to blame but appears herself to suspect that end of life was the cause of the patient's fainting.Although at the time when the fainting first began the device was not at end of service.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8519789
• MDR Text Key: 142114330
• Report Number: 1644487-2019-00735
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/20/2015
• Device Model Number: 104
• Device Lot Number: 202801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2014
• 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): Other; Required Intervention
• Patient Age: 54 YR