MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Fatigue (1849); Hypoesthesia (2352); Neck Pain (2433)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had a seizure and the magnet was used, and the patient reports that since the seizures had stopped the generator feels as if it is continuously stimulating (similar to magnet mode stimulation going off constantly).The patient was noted to be experiencing throat tightness, hoarseness, tingling of the head and generalized fatigue.It was noted a similar issues occurred for the patient's first vns which required replacement, which is reported in manufacturing report number: 1644487-2021-00006.Diagnostics were reported to be within normal limits.The patient's explanted device has not been received to date.No additional relevant information has been received to date.

Event Description

Information was received that per the physician the cause of the continuous stimulation, painful stimulation (throat tightness), voice alteration, hypoesthesia, and fatigue are related to vns stimulation and "possibly" due to low battery, as the patient reported similar symptoms in 2015 when previous generator battery life was at end of service (contained in manufacturing report number 1644487-2021-00006).It was stated that per the physician, the current and previous battery replacements were performed in 2015 and 2020 due to the patient's report that he feels the vns device was/is firing abnormally, as if the magnet is being used constantly.Generators were both replaced for patient comfort and to preclude a serious injury.No additional relevant information has been received to date.

Event Description

The suspect device was received by the manufacturer and product analysis was completed.The reported patient adverse events are beyond the scope of the pa lab; however, proper generator functionality was verified.The generator output was monitored for >24 hours and no variations in the device output were noted.Additionally, the septum was not cored, indicating no expected current leakage path associated with the generator.Comprehensive electrical testing showed that the generator performed according to all functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 11109079
• MDR Text Key: 224801118
• Report Number: 1644487-2021-00007
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2022

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: 08/08/2016
• Device Model Number: 105
• Device Lot Number: 4024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/14/2021; 02/25/2022
• Supplement Dates FDA Received: 02/04/2021; 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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: 49 YR
• Patient Sex: Male