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

Model Number 1000

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Convulsion, Clonic (2222)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

Internal field number: (b)(4).

Event Description

It was reported that the patient presented with error code 6 upon interrogation and the device was deactivated.The patient had an increase in seizures over baseline.The rep was eventually able to re-activate the device.Data review confirmed normal diagnostics and reboot reason 6, the generator was in a stim stopped state.This event is consistent with the issue associated with the gc5 recall which affects some m1000 generators with sn >100,000.For these events, the root cause of the unexpected device reboot is related to a hardware bug within the microcontrollers used in these devices and interaction with the device firmware.The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.The generator was manufactured before the screening process was implemented to mitigate the potential for gc5 reboots.No further relevant information has been received to date.

Event Description

A non-invasive firmware upgrade was performed on the generator to prevent future reboots.Additionally earlier data was reviewed for the patient generator which indicated that a device reset had occurred on (b)(6) 2019.The device had been re-enabled on an unknown date as data from (b)(6) 2019 shows that the device was enabled.This was most likely also related to gc5 reset, as the device is already known to be susceptible, however additional tablet data is needed to confirm this.No other relevant information has been received to date.

• 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: 12647743
• MDR Text Key: 276889393
• Report Number: 1644487-2021-01437
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2021
• Device Model Number: 1000
• Device Lot Number: 6249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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 Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female