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

Model Number	103 HP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Skin Infection (4544)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to the size of the implanted device, the patient opened the incision leading to infection.The device was removed and replaced.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy 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.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.

• 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: 23938027
• Report Number: 1644487-2025-11034
• Device Sequence Number: 21239436
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/14/2017
• Device Model Number: 103 HP
• Device Lot Number: 4351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2015
• 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; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male