MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problems Failure to Interrogate (1332); Defective Component (2292)

Patient Problem Seizures (2063)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

Patient presented with an increase in seizures and their device was not able to be interrogated despite using three different programming systems.It was indicated that the patient's generator could be palpated, but the generator could not be found when trying to interrogate.The patient was referred to surgery and underwent a generator replacement.The explanted device has not been received by the manufacturer to date.A review of device history records revealed that the generator passed all functional specifications and quality tests prior to distribution.No other relevant information has been received to date.

Manufacturer Narrative

H6 adverse event problem codes , corrected data: follow-up report #1 inadvertently left blank.

Event Description

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

Event Description

Product analysis was completed on the returned generator.The allegations of ftp and no stimulation were duplicated in the pa lab.The electrical tests performed in the pa lab found that the generator was at an eos = yes condition.The battery voltage was measured at 1.854 volts, and the memory locations on the generator indicated that 100.649% of the battery had been consumed.The pulse generator as received felt swollen and did not meet the thickness specifications.The microprocessor (a1) was found to be the contributing factor for the reported allegations but the failure mechanism for the microprocessor (a1) was not established.

Event Description

Internal data was received and reviewed from the suspect generator.

Event Description

Additional product analysis was completed on the returned generator.Additional testing revealed multiple resets occurred but the cause of the resets could not be determined.Running the microcontroller on the breadboard failed (reset) between 5 and 10 days after starting.Additionally, attempts at jtag communication and communication with wandcomm were very inconsistent and seldomly successful.The cause of the reset could not be determined.

• Brand Name: PULSE GEN MODEL 1000
• 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: 11096017
• MDR Text Key: 224397992
• Report Number: 1644487-2020-01754
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2021
• Device Model Number: 1000
• Device Lot Number: 204805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/12/2021; 05/06/2021; 12/02/2021; 03/21/2022; 10/20/2022
• Supplement Dates FDA Received: 04/06/2021; 05/06/2021; 12/22/2021; 04/15/2022; 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2019
• 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 Age: 35 YR
• Patient Sex: Female