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

Model Number MODEL 3000

Device Problems Computer Software Problem (1112); Energy Output Problem (1431); Communication or Transmission Problem (2896)

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

Event Date 01/07/2020

Event Type  malfunction  

Event Description

It was reported that the generator turned off unexpectedly and the patient could not feel stimulation.It was noted that this only happened once and the device was turned back on.The nurse practitioner does not recall a faulted diagnostic test occurring.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The patient's generator was replaced prophylactically.The explanted generator was discarded after surgery.No other relevant information has been received to date.

Event Description

Review of the physician's tablet data revealed that the change in settings was due to a faulted diagnostics test, which resulted in an inadvertent change in parameter settings.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10143498
• MDR Text Key: 194829189
• Report Number: 1644487-2020-00791
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2015
• Device Model Number: MODEL 3000
• Device Lot Number: 202608
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR