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

Model Number 302-20

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 12/07/2015

Event Type  malfunction  

Event Description

It was reported by the explanting surgeon the lead was not on the nerve.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Describe event or problem; corrected data: this information was inadvertently left off of the initial mfr.Report.

Event Description

The patient was referred for explant surgery as it was reported, she experienced a lack of efficacy.It was reported the lead was placed on the incorrect nerve; it was not placed on the vagus nerve.

Event Description

A review of the programming history database, which included information from 11/25/2002 through 06/13/2005, showed the patient's device had been programmed off on (b)(6) 2005.There was no additional history in the database after (b)(6) 2005.Only one diagnostic test was performed which showed results which were within normal limits for normal mode diagnostics.No additional relevant information has been received to date.

Event Description

Information was received via clinic notes for the patient's reimplantation surgery that the vns gave the patient a "different kind of discomfort".Further information was received from the neurologist that the patient's explant per the neurologist's notes was solely due to the vns not helping with the patient's seizures, and at the time of explant there was no indication that the explant was due to the discomfort.No additional relevant information has been received 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5335496
• MDR Text Key: 35171194
• Report Number: 1644487-2015-06868
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/29/2019

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: 10/31/2004
• Device Model Number: 302-20
• Device Lot Number: 7109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/04/2019
• Supplement Dates FDA Received: 02/15/2016; 02/23/2016; 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2002
• 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: 49 YR