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

Model Number	1000-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Convulsion, Clonic (2222); Insufficient Information (4580)
Date of Event	05/01/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient passed away due to unknown reasons.The physician performing post-mortem has explanted the vns and has inquired if the device was working properly before the patient died as the patient's family did not believe the device was working properly.The device had yet to be interrogated.It was later reported that no further information would be available until the pathologist sends a report.The explanted device has not been received to date.No other relevant information has been received to date.
Additional 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 or Problem Description
It was later reported that the device was interrogated.The device is showing high impedance and low output current due to it no longer being connected.Therapy remains enabled.The rep has advised that we cannot say whether this was an issue prior to disconnection without conducting a data download.The high impedance will not be captured as this is expected when the device is not connected to lead and nerve.No other relevant information has been received to date.
Event or Problem Description
It was later reported that the family apparently did not think the device was working because she had recently had an increase in seizures which was never reported and the device was not checked prior to the death.The coroner is not suggesting anything was wrong with the vns system.The device is available for return.No other relevant information has been received to date.
Event or Problem Description
It was later reported the estimated date that patient experienced an increase in seizures.The date of death was provided.Session report received.In respect of reaching out to the coroner and the physician for the cause of death and increased seizures, the local rep is unable to do this as this is deemed as confidential information.The device has shipped.The explanted device has not been received to date.No other relevant information has been received to date.
Event or Problem Description
The device has been received into product analysis.No other relevant information has been received to date.
Event or Problem Description
Product analysis was approved on the generator.Visual observations are most likely associated with manipulation of the device during the implant/explant procedures.There were no performance, or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 1000-D
• Common Device Name: 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: 20324318
• Report Number: 1644487-2024-01222
• Device Sequence Number: 8005486
• Product Code: LYJ
• UDI-Device Identifier: 05425025750528
• UDI-Public: 05425025750528
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/27/2025
• Device Model Number: 1000-D
• Device Lot Number: 787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 10/25/2024; 11/20/2024; 01/20/2025; 02/14/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/18/2024; 11/19/2024; 12/12/2024; 02/12/2025; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 50 YR
• Patient Sex: Unknown