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 Problems Weight Changes (2607); No Code Available (3191); Gastrointestinal Hemorrhage (4476)

Event Date 08/03/2018

Event Type  Injury  

Event Description

It was reported by the patient that they were experiencing painful stimulation in the stomach and had lost a good amount of weight.It was stated by the physician that the events were attributed to vns stimulation.It was noted that only vns setting adjustment was performed and the events improved with the adjustment.No additional relevant information has been received to date.

Event Description

It was reported by the patient that she was told to be having the side effect of anorexia due to vns stimulation.It was noted that the patient had experienced the events for the past two years due to vns stimulation being programmed to high.The patient was noted to be doing better after settings adjustment.The physician confirmed that the anorexia was related to vns stimulation.No additional relevant information has been received to date.

Event Description

Patient reporting suffering from gastroesophageal reflux disease and found bleeding in esophagus.It is unknown if the device caused the issues.Patient also has trouble gaining weight and only weighs 103 lbs.No additional relevant information has been received.

Event Description

Per the physician, the gastroesophageal reflux disease is unrelated to vns.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 10454771
• MDR Text Key: 204390632
• Report Number: 1644487-2020-01124
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2018
• Device Model Number: 106
• Device Lot Number: 4851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 04/14/2023; 05/24/2023
• Supplement Dates FDA Received: 10/16/2020; 05/09/2023; 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2016
• 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; Other
• Patient Age: 49 YR
• Patient Sex: Female