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

Model Number 3000

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Convulsion, Clonic (2222)

Event Type  malfunction  

Event Description

It was reported by health (b)(6) that medical device report was submitted by a hospital for a m2000 wand and m102 generator.Search was performed on health (b)(6) online database for incident reports.The following events were coded: convulsion seizure, computer software problem, patient-device incompatibility, communication or transmission problem, interrogation problem, testing of actual/suspected device, configuration issue, incorrect data definition, unintended use error caused or contributed to the event.It was noted the event had potential for death/injury.Based on the context of software issue caused by user error leading to increased seizures, the event was most likely a faulted diagnostics.It is known that the m102 generator is susceptible to settings changes if diagnostics tests are interrupted.This happens because on m102 generators, diagnostics tests reprogram the patient's settings to run the diagnostic test and then will reprogram the generator, back to intended settings, so if the diagnostics test is interrupted, then settings may not be corrected to intended settings if a final interrogation prior to ending a programming session to check settings is not performed as recommended, the patient may be left at this settings change.No further relevant information has been received to date.

Manufacturer Narrative

A2.Age at time of event; date of birth ¿ correction ¿ inadvertently did not include age or date of birth on initial mdr submitted.A3.Gender ¿ correction ¿ inadvertently did not include gender on initial mdr submitted.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14398167
• MDR Text Key: 291727641
• Report Number: 1644487-2022-00551
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 26 YR
• Patient Sex: Female