MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Twitching (2172); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/12/2019

Event Type  Injury  

Event Description

It was reported that the patient had lost 100 pounds causing their generator to shift down and to the side.After the migration occurred the patient reported that when the vns would stimulate, this would cause her left arm to twitch.Per the physician, the arm twitching was only occurring with stimulation and the patient had discomfort at the generator site upon palpation of the device.The surgical intervention taken was for patient comfort only or to preclude a serious injury.The surgeon noted that the leads looked like they were coming out of the device so during the replacement, he repositioned the leads as he felt this was likely the cause of the arm twitching.The explanted generator has not been received by product analysis to date.No other relevant information has been received to date.

Event Description

The explanted generator was received but product analysis is still underway.

Event Description

Product analysis was completed on the generator.The electrical tests performed in the pa lab found that the generator was at an ifi = no condition.The battery voltage was measured at 2.965 volts, and the memory locations on the generator indicated that 41.017% of the battery had been consumed.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.There were no performance, or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 1000
• 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: 12507999
• MDR Text Key: 272525780
• Report Number: 1644487-2021-01325
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Report Date: 11/22/2021

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: 06/20/2021
• Device Model Number: 1000
• Device Lot Number: 204988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 09/29/2021; 10/29/2021
• Supplement Dates FDA Received: 10/22/2021; 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• 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): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female