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

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.

• 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
• Report Number: 1644487-2018-01044
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,OTHER
• Reporter Occupation: OTHER CAREGIVERS
• Type of Report: Initial
• 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