MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Post Operative Wound Infection (2446)

Event Date 03/07/2008

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient had been explanted due to infection.It was reported that the patient had a generator revision performed on (b)(6) 2008.The reason for the revision could not be provided.The patient then had a generator explant on (b)(6) 2008 due to infection at the generator site.The cause of the infection was not able to be specifically provided, but was expected to be related to surgery.It was noted that the patient was later hospitalized due to a continuation of the infection, which lead to sepsis.The events were reported to have later resolved with medical intervention.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.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No additional relevant information has been received to date.

Manufacturer Narrative

Correction - event date should have been captured as (b)(6) 2008 in initial mdr.Correction - aware date should have been captured as (b)(6) 2021 in initial mdr.Adverse event problem - correection - b14 should have been included in initial mdr.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11979597
• MDR Text Key: 255592088
• Report Number: 1644487-2021-00804
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2008
• Device Model Number: 102
• Device Lot Number: 015579
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 49 YR