MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the patient's vns had reached the 25% battery status and it was suspected that this was reached prematurely.A review of device history records for the generator was performed and shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.No additional or relevant information has been received to date.

Manufacturer Narrative

Date received by manufacturer (mo/day/yr) ; corrected data; initial report submitted incorrect date of 11/07/2018 which should have been 11/06/2018.

Event Description

An internal battery life calculation was performed and predicted that as of the time of the 25-50% battery status the generator had 1.9 years remaining based on the data provided.Given that the generator had been implanted roughly 1.45 years, and given that the generator's battery status of 25-50% is not based on the voltage but actually on charge consumed (based on stimulation provided) , it can be reasonably concluded that the generator depleted normally.

• Brand Name: PULSE GEN MODEL 104
• 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: 8122643
• MDR Text Key: 129046172
• Report Number: 1644487-2018-02181
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2018
• Device Model Number: 104
• Device Lot Number: 5157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 18 MO
• Event Location: Other
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2017
• 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 Age: 29 YR