MAUDE Adverse Event Report: LIVANOVA USA, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 3000

Device Problem Energy Output To Patient Tissue Incorrect (1209)

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

Event Date 05/22/2018

Event Type  malfunction  

Event Description

It was reported that upon interrogation this patient's settings were found to be at 0ma, and the doctor does not know how this happened.It was stated that the patient was programmed to 3.25ma, and after the 1st interrogation the patient's settings for auto, normal and magnet mode were all set to 0.0ma and autostimulation was disabled.The staff noticed this behavior and therefore tried to increase the patient¿s settings back to the settings the patient was previously set to, but could only increase the patient's settings to 1.375ma due to tolerability issues.No other relevant information has been received to date.

Event Description

Internal investigation identified that the software will provide an invalid parameter values warning and set all output currents to zero if specific criteria are met, which include: a m106 ipg with at least one of magnet and/or autostim output current programmed to 3.5ma and normal mode output current programmed to less than 3.5ma.Autostim is enabled.Frequency and the other currents meet the following criteria: frequency - 25hz / normal mode output current - 3.25ma / autostim or magnet current is at least - 3.25ma.A frequency change has not occurred since the last time the 3.5ma current(s) was programmed.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7596099
• MDR Text Key: 110883106
• Report Number: 1644487-2018-01017
• 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
• Report Date: 08/01/2018

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: 07/07/2018
• Device Model Number: MODEL 3000
• Device Lot Number: 303873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• 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: 38 YR