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 Problem Unspecified Infection (1930)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description

At the patient's initial programming appointment, the surgeon identified subcutaneous exudate under the patient's chest implant site without swelling or pain of the skin.As a result, the patient was admitted to the hospital.During the hospitalization, the subcutaneous exudate was drained and the wound tested positive for non-resistant staphylococcus aureus.The patient was prescribed antibiotics and remained in hospital for observation.The device history records of the patient's generator was reviewed and sterilization of the device prior to release was verified.No further relevant intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient's generator was explanted due to the infection.The manufacturer's device history records of the patient's lead was reviewed and sterilization of the device prior to release was verified.No further relevant information has been received to date.

Manufacturer Narrative

Unique identifier #, corrected data: initial report inadvertently listed "na" instead of "(b)(4)".

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7900688
• MDR Text Key: 121436177
• Report Number: 1644487-2018-01674
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Model Number: 102
• Device Lot Number: 204369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 YR