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 No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Event Description

A report was received stating that the patient has swelling in the left breast (described as gynecomastia left, hall grade 2, tanner b2-3).The physician stated that it was difficult to tell if there is connection to vns and the swelling as he has never seen this before with other patients.

Event Description

Patient has a left-sided painful breast enlargement with no secretion.The doctor palpated the enlargement of the glandular body just above the nipple.A mamma-sonography was performed and it identified an unilateral gynecomastia without malignancy.There is no pre-existing testicular diseases, abdominal surgery or thromboembolic events in the history.There are no indications of endocrine disruption as the cause.In particular, hyperprolactinemia was excluded.Total testosterone is slightly more detectable but there are no indications for an androgen or estrogen excess.Patient was prescribed medication.Surgical option was also discussed.However, no known surgical interventions have occurred to date.Patient was also recommended an ultrasound examination and to visit an urologist / andrologist.The physician reported that they do not see a connection between the scalp/enlargement and the vagus nerve stimulator.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7528145
• MDR Text Key: 108719355
• Report Number: 1644487-2018-00818
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2017
• Device Model Number: 106
• Device Lot Number: 4618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• 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: 24 YR