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

Model Number 3000

Device Problem Computer Software Problem (1112)

Patient Problem Seizures (2063)

Event Date 01/19/2019

Event Type  Injury  

Event Description

It was reported that upon interrogation it appeared that the patient's m102 had been reprogrammed to 30 to incorrect settings.The physician wanted to know why this event occurred and if it could have contributed to the patient's increased seizures.Review of the data found that an interrupted communication had led to faulted diagnostics on the patient's generator at the last appointment.M102 generators change settings from programmed settings to diagnostics settings back to programmed settings to run system diagnostics; therefore, when the diagnostics were interrupted, the settings were left at the diagnostics settings.The physician did not run a final interrogation as recommended per labeling so this settings change was not found and corrected until the next appointment.No further relevant information has been received to date.

Event Description

It was reported that the patient's increased seizure rate was worse than their pre-vns seizure rate.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 8764707
• MDR Text Key: 150152094
• Report Number: 1644487-2019-01298
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2018
• 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 Outcome(s): Other
• Patient Age: 20 YR