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 10/22/2018

Event Type  malfunction  

Event Description

It was reported that the patient's generator was suspected to have depleted too quickly.The generator had been implanted about a year and was showing 25% remaining.A review of the device history record indicated that the generator had been laser-routed which has been shown to produce excess debris on the circuit board.This debris may lead to excess current draw from the generator, which can deplete the battery prematurely.No additional relevant information was received to date.

Event Description

Surgery was performed and indicated per the implant card to be prophylactic replacement.Post-operatively, the patient was programmed to intended settings as instructed by the neurologist.It was indicated that the facility would not be returning the device.No device was returned to date.No additional relevant information was received to date.

Event Description

Decoded programming data was reviewed and found that the battery depletion appeared to be within normal limits, and no anomalies were noted or suspected.It was reported that the patient's device was now almost depleted.She was reporting an increase in depression, which was causing her to be sleeping about 16 hours a day.Follow up with the physician noted that the increased depression was above pre-vns baseline levels.It was stated that the patient was now more depressed with the low battery levels, despite the same medication dosage.The device was able to be interrogated at the last visit and was showing about 20% battery life remaining.No additional relevant information was received to date.No surgery was performed to date.

• Brand Name: PULSE GEN MODEL 106
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8083285
• MDR Text Key: 127549846
• Report Number: 1644487-2018-02084
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2019
• Device Model Number: 106
• Device Lot Number: 204095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 11/28/2018; 12/24/2018
• Supplement Dates FDA Received: 12/13/2018; 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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: 59 YR