MAUDE Adverse Event Report: HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number	1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extreme Exhaustion (1843); Implant Pain (4561)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
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 reported that the after months of having the device implanted, the patient began experiencing chest pain, fatigue, and persistent tiredness.It was stated that after attempting to manage all the clinical symptoms the patient was presenting, they decided to refer him to the neurosurgeon to relocate the generator to the right pectoral area.No additional relevant information has been received to date.
Additional Manufacturer Narrative
B3.Date of event; corrected information; initial mdr inadvertently included incorrect information in initial submission.
Additional Manufacturer Narrative
Correction; mfr.Rep # 1644487-2025-10842 captures the investigation for this event.No further investigation will occur in mfr.Rep # 1644487-2025-10863.
Event or Problem Description
This event (mfr.Rep # 1644487-2025-10863), was discovered to have captured a duplicate event.The lead information in this file was not available in mfr.Rep # 1644487-2025-10863 at the time of file creation and the generator information was not available in mfr.Rep # 1644487-2025-10842 at the time of its creation.As a result, duplicate investigations were conducted and duplicate mdrs submitted.To reconcile, a correction will be submitted to identify mfr.Rep# 1644487-2025-10842 as the "correct file" which will continue the investigation for this event.This will house any future supplemental reports.As a result, mfr.Rep # 1644487-2025-10863 will no longer be utilized to continue the investigation.No additional supplemental information will be assessed for this file.

• Brand Name: PULSE GEN MODEL 1000
• Common Device Name: GENERATOR
• Manufacturer (Section D): HOUSTON; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 23624801
• Report Number: 1644487-2025-10863
• Device Sequence Number: 8977200
• Product Code: LYJ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2025
• Device Model Number: 1000
• Device Lot Number: 7616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 03/09/2026; 04/14/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/09/2026; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2023
• 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
• Patient Age: 17 YR
• Patient Sex: Unknown