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

Model Number 1000

Device Problem Output below Specifications (3004)

Patient Problem Convulsion, Clonic (2222)

Event Date 09/11/2023

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

The patient was seen in clinic and presented with low output current when their device was checked.The patient also reported experiencing a recent increase in seizures.The patient has since been referred for surgery.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient recently had 3 big seizures and would like for her replacement surgery to be moved up.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

The explanted generator was received and product analysis is underway.

Event Description

Product analysis was completed on the returned generator.An interrogation and a system diagnostic test were performed.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation (shows an ifi=no condition) was performed.The dut interrogated and tested in the livanova product analysis lab.Based on the function analysis the ¿energy output to patient tissue incorrect output current low¿ allegation was not confirmed in the product analysis lab.

• 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: 17889365
• MDR Text Key: 325138181
• Report Number: 1644487-2023-01439
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/16/2021
• Device Model Number: 1000
• Device Lot Number: 6166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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: 42 YR
• Patient Sex: Female