MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Device Inoperable (1663)

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

Event Date 11/01/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was no longer functioning.The patient was referred for surgery but no known surgical interventions have occurred to date.No further information relevant to the event has been received to date.

Event Description

No surgical intervention has taken place to date.

Event Description

It was reported from the physician that the report that the "device stopped working" does refer to a device malfunction.System diagnostic results from (b)(6) 2015 showed that the device at high impedance.

Manufacturer Narrative

Brand name, corrected data: changed suspect device from generator to lead model 302 type of device, name, corrected data: changed suspect device to lead.Model #, serial #, lot#, expiration date, corrected data: changed to 302-20, 32099, 200340, 09/30/2009.Device manufacture date, corrected data: changed to lead date: (b)(6) 2006.

Event Description

On (b)(6) 2015 referral clinic notes were received.The notes dated (b)(6) 2015 state that the patient is doing ok but the vns is not working.The patient is working on insurance to approve the replacement procedure.Notes state that overall the patient is improving and is less depressed but without the benefit of the vns functioning properly she has been a little worse.The physician noted the device was checked and the parameters were left the same, both system and normal mode tests failed.Notes from (b)(6) 2015 state that she has had some fatigue and decreased motivation likely related to the vns malfunction.Although surgery is likely, it has not occurred to date.

Event Description

It was reported on 02/18/2016 that the patient's generator was unable to be interrogated but they knew the patient had high lead impedance.The physician did not want to revise that day.The generator was replaced that day but the lead was not because of time.The explanted generator will not be returned due to the hospital protocol.

Event Description

The patient underwent surgery on (b)(6) 2016.The surgeon didn't think there was room to place the anchor tether on the vagus nerve due to scar tissue build up.Therefore, the lead was not removed.No known further interventions were taken to remove or replace the device.

Event Description

Programming history data revealed the another date in which high impedance was seen.It was later reported that the physician, dr.Nardone, stated that the there was too much scar tissue to replace the lead.This, fibrosis is already present in the file (comment 57).No surgery has occurred to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 4392292
• MDR Text Key: 5368613
• Report Number: 1644487-2015-03542
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/29/2024

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: 09/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 02/05/2024
• Supplement Dates FDA Received: 02/16/2015; 06/08/2015; 03/14/2016; 05/06/2016; 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2006
• 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: 52 YR
• Patient Sex: Female