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

Model Number	3000-V1.5
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	03/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that the patient was referred for replacement due to unknown reasons.A call was later received from the physician¿s office informing that the reason for replacement due to the patient¿s high lead impedance that resolved, which the physician understood to be a result of battery depletion.The clinic notes were further evaluated and it was discovered that the physician interrogated the vns with the output currents programmed on.This resulted in "lead impedance 6600-7700 ohms.¿ the physician then turned the magnet and the output to 0ma and rechecked the diagnostics.At this time, the lead impedance was back to normal between 4100-5200ohms.The physician noted that the only explanation to this event was low battery which needs to be replaced.The battery status of the generator was not provided within the clinic notes.Further follow up confirmed that the system diagnostics testing was performed using the (b)(6) software.It was determined that the cause of this false high impedance message was a software error on (b)(6) software; when system diagnostics were performed by the user with (b)(6) 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.No other 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: 8864177
• Report Number: 1644487-2019-01515
• Device Sequence Number: 16833016
• Product Code: LYJ
• UDI-Device Identifier: 05425025750429
• UDI-Public: 05425025750429
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 3000-V1.5
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR