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

Model Number	1000-D
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's physician suspects a possible lead fracture and wants to send in x-ray images to be reviewed.X-ray images have not been reviewed to date by livanova.No known surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
Additional information received noting that the patient has not experienced any recent trauma or manipulation.
Event or Problem Description
Additional information received noting that the patient underwent an exploratory surgery, and the lead was found to be loose.The surgeon tightened the lead and no devices were replaced.
Event or Problem Description
Per the physician, the bottom electrode lead was not screwed into place, onto the ipg site.The physician noting "the bottom electrode lead was not screwed into place onto the ipg site" this will be assessed as incomplete pin insertion being the cause of the high impedance.

• Brand Name: PULSE GEN MODEL 1000-D
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 22379500
• Report Number: 1644487-2025-10317
• Device Sequence Number: 8430038
• Product Code: LYJ
• UDI-Device Identifier: 05425025750528
• UDI-Public: 05425025750528
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2026
• Device Model Number: 1000-D
• Device Lot Number: 206384
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 08/29/2025; 12/26/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/29/2025; 09/23/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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: A
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female