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

Model Number 106

Device Problems No Display/Image (1183); Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2018

Event Type  malfunction  

Event Description

It was reported that the patient's vns was implanted less than a year and was displaying an intensified follow-up indicator, or ifi, = yes condition.However, clinic notes were received that indicated that the vns generator battery was at the 11-25% range, which indicates an ifi = no condition.The clinic notes indicated that the patient's vns settings were reduced to help with battery life.The patient was referred for vns replacement surgery.A review of device history records revealed that the vns generator was not affected by the laser routing manufacturing process.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

Event Description

The tablet data for the generator was received and reviewed by the manufacturer.The observed discrepancy between the diagaccumconsumed values and the battery voltages are an indication that the battery was depleting faster than expected.Impedance was within the normal limits throughout the available programming history.There was no evidence that an electrocautery tool came into contact with the device at implant.An internal investigation was completed on premature battery depletion events.The results of the investigation observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in leakage paths.This finding is indicative that the generator will reach true end of service earlier than expected.

Event Description

Information received that the patient underwent a vns generator replacement due to battery depletion.Device return is not expected as the explanting facility historically discards devices per the facility's policies.No additional or relevant information has been received to date.

Manufacturer Narrative

Age at time of event, corrected data: follow-up report #2 inadvertently left out the updated age "(b)(6)".Date of event, corrected data: follow-up report #2 inadvertently left out the updated date "(b)(6) 2018".

Event Description

Review of the data in the decoder revealed that it was believed that there was no indication of a malfunction present with the generator.The temporary low battery indicator was due to the aggressive settings and the large current draw, which was the result of the high duty cycle (51%) and the large pulse width.The battery voltage drops as the current draw begins and slowly rebounds to the previous voltage when the current draw ends.Due to the cyclical nature of vns on-off times, this results in a semi-sinusoidal nature of the battery voltage.With the settings present on the patient's vns, the on time for stimulation was 60 seconds with a 2 second ramp-up and 2 second ramp-down time and the off time was 1.1 minutes or 66 seconds.This results in a duty cycle of 51% which in combination with the high pulse widths (500/750 microsecond) did not allow the battery voltage to fully rebound prior to discharging once again and dropping the battery voltage.Once the pulse width was lowered to 250 microsecond, the battery voltage was able to more fully rebound from the discharge state and the battery voltage was able to rise above the threshold for the 25% indicator flag as appropriate.It was determined that this was not an indication of a device malfunction, but due to the nature of the battery voltage/current draw.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #1 inadvertently reported the internal investigation for premature battery depletion events caused by conductive debris from the laser-routing process when the device was confirmed as not manufactured using the laser-routing process in the initial report.(b)(4).

• 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: 8089296
• MDR Text Key: 127914478
• Report Number: 1644487-2018-02108
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,Followup,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 106
• Device Lot Number: 5011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 12/07/2018; 01/09/2019; 01/18/2019; 03/08/2019
• Supplement Dates FDA Received: 12/17/2018; 01/10/2019; 01/30/2019; 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• 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: 28 YR