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

Model Number	MODEL 3000
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A high impedance event was identified during a periodic programming history review.High impedance dcdc 4 was detected with model 3000 version 1.5 software with system diagnostics.The same day system diagnostics detected ok impedance dcdc-2.On 1.5 software after the output currents were programmed off.It was previously determined through in-house testing that, for model 102/102r generators programmed to output currents > 1ma, system diagnostics using m3000 v1.0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1.5.2.1 software would display a false high impedance.The cause of these false high impedance messages was a software error on m3000 v1.5.2.1 software; when system diagnostics were performed by the user with m3000 v1.5.2.1 software on m102/102r generators (normal mode output current >0 ma), normal mode diagnostics would actually be performed instead.The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds.It was determined that m102/102r system diagnostics functioned as expected when the generator was programmed to 0 ma and provided a true impedance value.When the patient¿s generator was programmed to 0 ma, system diagnostics were ok; therefore, the high impedance originally observed was determined to be a false result.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9107959
• Report Number: 1644487-2019-01863
• Device Sequence Number: 16937247
• Product Code: LYJ
• UDI-Device Identifier: 05425025750429
• UDI-Public: 05425025750429
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: MODEL 3000
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/24/2019
• Patient Sequence Number: 1
• Patient Age: 47 YR