MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

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

Event Date 03/26/2019

Event Type  malfunction  

Event Description

It was reported that the patient¿s generator was at less than 25% after being implanted in 2017, and the physician believed that the patient¿s device may be prematurely depleting.Programming history was reviewed for the generator, and the settings on the day of implant were available.A battery life calculation was performed using the programming history and patient¿s current settings, and assumptions were made for any gaps if present.It was assumed that the patient's settings were changed halfway between the date of implant and the day the settings were given.There was 3.7 years predicted to near end of service.No anomalies were seen.Device history records were reviewed for the generator.The device passed all specifications prior to distribution, and the device was not laser routed, and would not be susceptible to premature depletion due to laser routing.The patient had not had any electrical current that may have damaged the generator pass through the body.Surgery is likely but has not occurred to date.No additional or relevant information has been received to date.

Event Description

It was noted that the patient's generator is now at near end of service (neos) = yes.No other additional relevant information has been received to date.No known surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8520127
• MDR Text Key: 142355315
• Report Number: 1644487-2019-00728
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2019
• Device Model Number: 106
• Device Lot Number: 204124
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR