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 Fatigue (1849); Seizures (2063)

Event Date 02/18/2020

Event Type  Injury  

Event Description

It was reported by the patient's parents that the patient has had a change in energy and seizures, and thus they are going forward with the generator change.It was stated that the patient seems more lethargic and fatigued and seizures seem to be increasing.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient's seizures are above pre-vns baseline.When asked for the physician's assessment, it was stated the battery was very low on the vns and it was unclear how much it had help since its implantation.Thus before deciding to replace the battery, the physician trialed turning the vns off, which led to the increase in seizures.Thus the generator was determined to be efficacious.There are no reported external factors contributing to the seizures.The relationship between the patient's fatigue/lethargy and the vns was that they were related to the increase in seizures due to the vns being off.The patient's referral for replacement is not due to the increase in seizures/fatigue.The reason for replacement was noted to be "needs a new battery or updated device".No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that the patients generator was replaced due to battery depletion.The patient's replacement surgery facility is a no return site therefore the explanted product has not been received into analysis to date.No additional 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
• MDR Report Key: 9831409
• MDR Text Key: 183338782
• Report Number: 1644487-2020-00443
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 0105425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/27/2018
• Device Model Number: 106
• Device Lot Number: 203844
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 03/16/2020; 05/14/2020
• Supplement Dates FDA Received: 04/09/2020; 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR