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

Model Number 1000

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Event Description

During internal review of programming data, a m1000 was found to have experienced an suspected gc5 reset.The reset was observed on (b)(6) 2021 @ 3:08 with reboot reason 6 and reboot counter of 2.This event is consistent with the issue associated with the gc5 recall which affects some m1000 generators.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 additional relevant information has been received.

Manufacturer Narrative

(b)(4).

Event Description

Follow up with the provider confirmed the patient's generator has been working properly seen may 2022 when settings were last adjusted.No additional relevant information has been received.

• 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: 13064810
• MDR Text Key: 283846550
• Report Number: 1644487-2021-01808
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2021
• Device Model Number: 1000
• Device Lot Number: 204888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2019
• 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: 45 YR
• Patient Sex: Female