MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 10/24/2018

Event Type  malfunction  

Event Description

It was reported that the patient is being referred for vns generator replacement with the generator battery indicating 8-18%.The patient's mother stated that she was told the device would last 8 to 10 years however the patient was having to undergo replacement 5 years after implant.No other relevant information has been received to date.Surgical intervention has not occurred to date.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #1 inadvertently did not provide the results from a battery life estimate.Relevant tests/laboratory data, including dates , corrected data: follow up report #1 inadvertently did not provide the battery life status and results of the battery life estimate evaluation codes , corrected data: follow up report #1 inadvertently did not list the methods, results, and conclusion codes.

Event Description

A battery life estimate was performed based on the settings that were reported for the device and it indicates that the battery depletion is normal.

Manufacturer Narrative

Relevant tests/laboratory data, corrected data: supplemental mdr #2 inadvertently provided the incorrect battery life estimate.

Manufacturer Narrative

Relevant tests/laboratory data, corrected data: initial report inadvertently provided the incorrect dates for settings.

Event Description

Information was received that the physician does not have all of the settings for the patient on the programming system due to a different programming system possibly being used at the time of initial programming for the patient.The physician provided the patient¿s programmed settings, dating back to when the generator was initially programmed on.No other relevant information has been received to date.

Event Description

It was reported that the patient underwent a prophylactic vns generator replacement.The facility at which the devices were explanted is historically a no return site as the facility discards devices after implant no other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 8130713
• MDR Text Key: 129341656
• Report Number: 1644487-2018-02205
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2015
• Device Model Number: 103
• Device Lot Number: 3610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• 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: 21 YR