MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Chest Pain (1776); Headache (1880); Neck Pain (2433); No Code Available (3191)

Event Date 11/27/2020

Event Type  Injury  

Event Description

It was reported that the patient feels that her device has been firing every 2-3 minutes instead of every 5 minutes.She is experiencing painful stimulation and hoarseness with stimulation.She went to the hospital to have the device turned off and she was admitted and put on morphine until the device could be disabled.The patient had noted that the magnet was not effective in disabling the device.On 12/8 the patient had the device turned back on to 1.75 ma (having been at 2 ma before) and she tolerated it well.The pain then returned about 18 hours later and both of the patient's magnets were not successful in disabling the device.Patient went back to the hospital and had the device disabled.It was noted that the pain began when the patient was laying in bed and there has been no trauma or falls.Physician is not sure of the cause of the pain.The pain was noted to be in the neck.It was also noted that the magnet was tested in clinic and it was successfully disabling stimulation.Information was received from the psychiatrist that it is difficult to attribute this psychologically due to the acute onset and since the pain stops when the device is deactivated.He noted that the patient had a significant injury in june in which she fell down the stairs, and he is not sure if chest compressions were performed, but the surgeon has noted that there was no damage to the implant.No other relevant information has been received to date.

Event Description

It was noted that the event resolved and the device was turned back on.No further relevant information has been received to date.

Event Description

It was noted that the pain had been in the upper left chest, back of the neck, and back of the head.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 11029095
• MDR Text Key: 222091126
• Report Number: 1644487-2020-01704
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2021

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: 03/05/2021
• Device Model Number: 103
• Device Lot Number: 204875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 04/12/2021; 11/24/2021
• Supplement Dates FDA Received: 05/06/2021; 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• 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: 31 YR
• Patient Sex: Female