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	11/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via a programming history database periodic review that the patient had high impedance.The high impedance was observed with (b)(4) software.The output currents were then all disabled and the high impedance was no longer observed.For model 102/102r generators programmed to output currents > 1 ma , it was observed that system diagnostics using m3000 (b)(4) and m250 software would display ok lead impedance while system diagnostics using m3000 (b)(4) software would display a false high impedance.No other relevant information has been received to date.
Additional Manufacturer Narrative
Corrected data, initial report: model number was inadvertently listed incorrectly.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9191882
• Report Number: 1644487-2019-02003
• Device Sequence Number: 11365072
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: Health Professional
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR