MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Seizures (2063)

Event Date 06/01/2019

Event Type  malfunction  

Event Description

It was reported that a patient is having an increase in seizures in the last month.No additional relevant information has been received to date.

Event Description

Generator analysis was completed.The generator was explanted due to the "intensified follow up indicator" (ifi) being set to yes, and this allegation was confirmed in product analysis (pa) lab.The allegation of increase in seizures cannot be evaluated in the pa lab however proper functionality of the generator and its ability to provide appropriate programmed current was verified.The device output was monitored for over 24 hours and showed no signs of variation in the output signal ad expected level of current output.The generator diagnostics were as expected for the programmed parameters.Comprehensive automated electrical evaluation showed the device performed according to functional specifications.There were no performance or any other type of adverse conditions found with the generator.

Manufacturer Narrative

(b)(4).

Event Description

Information was received that the patient's generator was replaced prophylactically (due to the battery status showing an " intensified follow-up indicator" (ifi) = yes.Information was received that per the physician it is unknown whether the patient's increase is above, at, or below pre-vns baseline, device diagnostics were within normal limits and the battery is at ifi yes, that the physician believes the increase in seizures is due to low battery, and it is unknown whether there are any factors contributing to the increase in seizures.The patient's generator has been received into analysis however product analysis has not been completed to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 8798610
• MDR Text Key: 151313988
• Report Number: 1644487-2019-01382
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 0542502575006
• UDI-Public: 010542502575006
• 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,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2018
• Device Model Number: 106
• Device Lot Number: 4770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• 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 Age: 20 YR