MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? no, device evaluation is not necessary because the reported event is not related to the functionality or delivery of therapy of the device.

Event Description

A company representative attended a surgery where the surgeon intended to either move the generator to a new pocket or to clean out the existing pocket due to infection.The surgeon performed the surgery and implanted a new generator on the left side (new pocket).No other relevant information has been received.A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Event Description

The physician reported that they believed the patient's infection to be related to a mastectomy surgery the patient underwent.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7301547
• MDR Text Key: 101113334
• Report Number: 1644487-2018-00297
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2018
• Device Model Number: 106
• Device Lot Number: 5160
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2017
• 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): Required Intervention
• Patient Age: 62 YR