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 04/01/2019

Event Type  Injury  

Event Description

It was reported from the physician that believes that the patient¿s m106 may be depleted.It was noted that the patient is having an increase in seizures which started a couple of weeks ago and the patient almost went into status epilepticus.The physician believes it could be due to the vns battery needing replacement.The physician stated that she believes the increase in seizures are due to the battery life of the generator however she would need further data on this.The physician was asked if she had run diagnostics to ensure that the patient's device is operating within normal limits, and the physician stated that she had done this and there were no issues noted.Additional information was received that the increase in seizures was above baseline and it was the worst seizures she has ever had.The physician stated that she wanted to know how to confirm there was no issue with the lead.She stated last time the patient went in for a battery change when she was referred in (b)(6) 2016 they found the lead was broken (mfr report # 1644487-2017-03071) however there was no indication in the programmer there was something wrong with the lead.She was informed she could refer for x-rays to further assess and stated that she would refer the patient to have this done but regardless the patient was being referred to have the battery replaced and if needed the lead as well due to the increase in seizures.She state that the battery was currently at ifi - no.No known surgical intervention has occurred to date.

Event Description

The patient's mother reported that the patient went into status epilepticus and was air lifted to a hospital.The battery was noted by the patient's physician assistant to not be depleted.

Event Description

It was later reported that patient had a generator replacement surgery.The explanted generator was disposed of per hospital policy.No other 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: 8595743
• MDR Text Key: 144575525
• Report Number: 1644487-2019-00885
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/27/2018
• Device Model Number: 106
• Device Lot Number: 203837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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: 21 YR
• Patient Sex: Female