MAUDE Adverse Event Report: LIVANOVA USA, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number	3000
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
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 have not 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 reported that the generator has showed a battery level of 11-25% since 2022.The device was replaced since the surgeon did not think it was possible for the generator to remain at this battery status for this extended amount of time.Other than the maintained battery status, there were no malfunctions.The explanted generator will be returned for product analysis but has not been received to date.No other relevant information has been received to date.
Event or Problem Description
It was reported that the generator was received into the product analysis lab.It was reported that the physician that he had misunderstood about the remaining battery.There is no device failure alleged by the provider.Session reports were later provided from the physician's programming tablet.It was confirmed that the physician misunderstood the patient's battery status - there is no device failure.As confirmed by the data, the generator reached 11-25% status on 2/20/2024, not two years ago as alleged by the physician.
Event or Problem Description
The generator underwent product analysis testing in which no anomalies/malfunctions were identified.No other relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING COMPUTER
• 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: 20292710
• Report Number: 1644487-2024-01203
• Device Sequence Number: 8127455
• Product Code: LYJ
• UDI-Device Identifier: 05425025750535
• UDI-Public: 05425025750535
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 11/12/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/22/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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
• Patient Age: 53 YR
• Patient Sex: Male