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 Cardiac Arrest (1762); Convulsion, Clonic (2222)

Event Date 05/27/2021

Event Type  malfunction  

Event Description

It was reported that the patient complained that he is having increase in seizures since replacement and pain at battery location.He reported to his following nurse practitioner that he wanted his vns taken out and a new one to replace it.During interrogation, the nurse practitioner found that vns was programmed to low settings.She reported that the device has had settings there since just after replacement surgery.Patient also said that vns has caused him to have 4 heart attacks but the nurse practitioner does not believe this to be true.They were attempting to get heart records from florida, where heart attacks were said to have occurred.Provider adjusted settings up.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that there was no evidence this patient had heart attacks, so they are not related to vns therapy.The cause of increase in seizures is that patient's vns battery depleted years ago and when vns generator was changed vns settings were low.It was never titrated back to previous settings because patient moved to out of state.The increase in seizures is back to pre-vns baseline levels as the patient was seizure free when vns generator wasn¿t depleted.The cause of pain is external factors not vns therapy.Intervention has been taken for the increase in seizures in the form of titrating vns back up to settings before battery depleted.

• 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: 14549909
• MDR Text Key: 293091801
• Report Number: 1644487-2022-00639
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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: 08/13/2022
• Device Model Number: 106
• Device Lot Number: 205369
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• 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: 43 YR
• Patient Sex: Male