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 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any; defects¿ or; malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was noted that the patient was recently seen in clinic and when their device was interrogated they received error code 6 (reset code) and the device was disabled.It was also reported that the patient has been experiencing an increase in seizures over the last few weeks.Internal data from the generator was received and reviewed.A device history records review for the m1000 generator performed.The generator passed final functional and quality specifications prior to release for distribution.The generator was confirmed to have been manufacturer with the new gc5 firmware.No other relevant information has been received to date.

Manufacturer Narrative

B5.Corrected event description, initial report: inadvertently left out details on further analysis.

Event Description

Further analysis was performed confirming that the gc5 reset is not the cause of the device issue.This was determined based on the fact that the device had the newest m1000 firmware which is not susceptible to gc5 resets.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17975236
• MDR Text Key: 326306827
• Report Number: 1644487-2023-01499
• 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
• Report Date: 06/18/2024

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 Model Number: 1000
• Device Lot Number: 206068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 06/18/2024
• Supplement Dates FDA Received: 06/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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: 17 YR
• Patient Sex: Male