MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Seizures (2063)

Event Date 03/06/2019

Event Type  malfunction  

Event Description

It was reported that the patient recently had an episode of increased seizures and went into status for 50 minutes.No additional information has been received to date.

Manufacturer Narrative

Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

Event Description

It was reported the patient's recent brain lesion and condition of cerebral palsy contributed to the increase in seizures.The neurologist and staff do not believe vns was the cause of the increase in seizures.They also want the battery replaced before it gets too low where issues would arise since vns has been effective for the patient.The patient is going to have surgery consult scheduled to have it replacement since current battery status of the patient is 11-25%.The patient underwent prophylactic replacement on (b)(6) 2019.

• Brand Name: PULSE GEN MODEL 106
• 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: 8461243
• MDR Text Key: 140208699
• Report Number: 1644487-2019-00611
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 106
• Device Lot Number: 4661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2015
• 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 Outcome(s): Other
• Patient Age: 28 YR