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

Model Number 103

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

Patient Problem Seizures (2063)

Event Type  Malfunction  

Event Description

A caregiving facility reported that a patient was experiencing an increase in seizures. The caretaker was unsure whether the patient's seizures were true seizures. No additional relevant information has been received to date.

Event Description

The patient underwent vns generator replacement. Device return is not expected as the explanting facility historically does not return explanted devices. System diagnostics were performed prior to replacement with all results being within normal limits. No additional or 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: 7623285
• MDR Text Key: 111875780
• Report Number: 1644487-2018-01044
• 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,OTHER
• Reporter Occupation: OTHER CAREGIVERS
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/20/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 10/31/2015
• Device MODEL Number: 103
• Device LOT Number: 3799
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Other
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 11/20/2013
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial