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 Problems Seizures (2063); Unspecified Heart Problem (4454)

Event Date 08/01/2016

Event Type  Injury  

Event Description

The patient reported having an increase in seizures in the following months after implant (implanted (b)(6) 2016).The information received suggested the device was programed on shortly after implant and the neurologist made no changes at a follow up visit one month later but suggested the patient visit again in one year.Since then the patient visited a new neurologist who reprogrammed the device's settings.The patient reported improvement in focal seizures since the change as well as fatigue and some cognitive changes.No diagnostics or additional settings have been received to date.No additional or relevant information has been received to date.

Event Description

Information was received stating the patient's neurologist assessed the increase in seizures was due to the need for titration of settings and did not believe there was an issue with the patient's vns system.Autostim diagnostics were provided and indicated normal function.No additional or relevant information has been received to date.

Event Description

The patient now reported that her device has been disabled for a while as the vns did not work for her and made her seizure activity worse.She noted that the vns also caused heart rate fluctuations and dyspnea.No further relevant information has been 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 7109367
• MDR Text Key: 94549381
• Report Number: 1644487-2017-04967
• 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: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2016
• Device Model Number: 106
• Device Lot Number: 203797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 1 YR
• Event Location: Other
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female