MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Chest Pain (1776); Local Reaction (2035); No Code Available (3191)

Event Date 11/02/2017

Event Type  Injury  

Event Description

It was reported that the patient feels her battery is sideways in her chest and is causing pain and inflammation.Per the physician, the pain, migration and inflammation was due to patient physiology and external factors; however, the patient was referred for a full revision.No known surgery has occurred to date.No additional relevant information has been received.

Manufacturer Narrative

Incorrect event date was included in initial mdr.

Event Description

Patient is continuing to experience swelling on the left side.No known surgery has occurred to date.No additional relevant information has been received.

Event Description

Additional information was received that the patient was found to have no swelling or infection.

Event Description

Per the field representative, impedance measurements were within normal limits.No additional relevant information has been received.

• Brand Name: PULSE GEN MODEL 104
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 10889014
• MDR Text Key: 217938475
• Report Number: 1644487-2020-01581
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/20/2019
• Device Model Number: 104
• Device Lot Number: 5495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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): Other
• Patient Age: 52 YR
• Patient Sex: Female