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 03/21/2019

Event Type  malfunction  

Event Description

It was reported that a patient did not think their vns device was working as he was having many bad seizures and has reportedly had more since his replacement surgery.The patient's device was interrogated and diagnostics showed that the device was functioning as intended.No settings were adjusted for the patient.No additional, relevant information was received.

Event Description

A fax response was received from the physician's office indicating that the seizure levels were below pre-vns baseline levels.Regarding the physician's assessment of the cause of the patient's increased seizures, it was stated that the patient has lennox-gastaut syndrome, takes 4 aeds in addition to vns, and has daily seizures with no apparent triggers.No additional relevant information was received to date.

• 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: 8519846
• MDR Text Key: 142115406
• Report Number: 1644487-2019-00736
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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: 08/01/2020
• Device Model Number: 106
• Device Lot Number: 005868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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: 22 YR