MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number	103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experiencing a minor infection at the vns site.It is believed to be caused by an infection at the foot and spread to the vns site.Medication was provided to the patient for the infection.Device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.Device history records were reviewed for the generator and lead.The generator and lead passed all specifications prior to distribution.The generator and lead were hp sterilized.No other relevant information has been received to date.
Additional Manufacturer Narrative
This event is associated with capa ca-0049 regarding previously unreported complaints from brazil.Device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.

• Brand Name: PULSE GEN MODEL 103
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 24203608
• Report Number: 1644487-2026-10146
• Device Sequence Number: 18594320
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/17/2023
• Device Model Number: 103
• Device Lot Number: 7071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• 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: Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Male