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

Model Number 106

Device Problem No Display/Image (1183)

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

Event Date 10/17/2018

Event Type  malfunction  

Event Description

It was reported that a patient's vns was showing a different battery status when interrogated with different programming systems.No additional or relevant information has been received to date.

Event Description

Exported programming data from the neurologist¿s tablet was received.The data was reviewed and confirmed that the device¿s battery status increased from the 11-25% to 25-50% status at a point in time.Based upon the available data, the different battery statuses seen resulted from a slight increase in battery voltage measured when a system diagnostic test was performed.Due to the battery voltage measuring just slightly above the 2.87v value that triggers the 11-25% battery status, the device displayed the 25-50% status as calculated by the percentage of battery consumed being approximately 57% (i.E.Greater than 50%).Therefore, there is no failure of the device and it is behaving as designed.There were no abnormalities or issues with the impedance values.Additionally, the data revealed that the 11-25% battery status triggered when only 15% of the battery was consumed.The device was programmed to aggressive settings for a period of time, and several programming and interrogation actions were observed in the data during each programming session which can cause additional battery drain.A battery life estimation was performed for the generator using the available data which ranged from (b)(6) 2018 (date of implant) through (b)(6) 2018.The results showed 0.9 years until neos and aligned with the observed battery depletion.Therefore, based on the generator settings, the device does appear to be depleting at the expected rate.No additional or relevant information has been received to date.

Event Description

Product information was received for two tablets the neurologist used and revealed that different software versions were on each tablet.No additional or relevant information has been received 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: 8081622
• MDR Text Key: 127548583
• Report Number: 1644487-2018-02082
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

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: 05/20/2019
• Device Model Number: 106
• Device Lot Number: 204153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 11/29/2018; 03/13/2019
• Supplement Dates FDA Received: 12/21/2018; 04/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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: 50 YR