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

Model Number MODEL 3000

Device Problems Computer Software Problem (1112); Fracture (1260); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/01/2019

Event Type  malfunction  

Event Description

It was reported that the patient was going to have their generator replaced for an unknown reason.Information was later received that the replacement would be due to prophylactic reasons, neos, and that the patient was "on a rapid cycle protocol + high lead impedances.No known surgery has occurred to date.No additional, relevant information was received to date.

Event Description

Patient underwent generator replacement surgery.Impedance was confirmed to be ok after generator replacement and pre-operative impedance was ok with version 1.0 software being used to perform the diagnostics.The explanted generator has not been received by product analysis to date.For model  102/102r generators programmed to output currents > 1 ma , it was observed that system diagnostics using m3000 v1.0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1.5 software would display a false high impedance.

Event Description

Confirmation was received from the physician's office that version 1.5 software was used when the high impedance was observed.The output currents were confirmed to be >0ma when the high impedance was observed.

Event Description

Further information was received that the explanted generator was discarded after surgery.

Event Description

Follow up with the physician's office clarified when the high impedance was first seen and confirmed that the high impedance was seen on a system diagnostics as an impedance range was provided, indicating that the diagnostic was performed on the newer programming systems which do not provide impedance ranges for normal mode diagnostics.No additional, relevant information was 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: 8538550
• MDR Text Key: 142773518
• Report Number: 1644487-2019-00760
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 3000
• Device Lot Number: 3316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR