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 08/19/2020

Event Type  Injury  

Event Description

The patient has been in and out of the hospital as well as the er due to an increase in seizures and seizures lasting over 5 minutes.The patient's device was checked while in the hospital and noted to have battery and to be working properly.The patient has been referred for a battery replacement.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.

Event Description

Generator analysis was completed and approved.The electrical tests performed in the pa lab found that the generator was at an eos=yes condition.During the bench interrogation, with a distance of one and one-quarter inches (spacer block) between the pulse generator and the programming wand, the pulse disabled and eos warnings were set.The pulse disabled byte would not reset.The battery voltage was measured at 1.958 volts, and the memory locations on the generator indicated that 114.610% of the battery had been consumed.A comprehensive automated electrical evaluation showed that the pulse generator pcba performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.

Event Description

The explanted generator was received, but product analysis is still underway.

• 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: 11285158
• MDR Text Key: 230453317
• Report Number: 1644487-2021-00174
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,Followup
• Report Date: 06/10/2021

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: 03/09/2019
• Device Model Number: 106
• Device Lot Number: 204069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Event Location: Other
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 03/04/2021; 04/21/2021; 05/18/2021
• Supplement Dates FDA Received: 03/29/2021; 05/14/2021; 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR