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); Protective Measures Problem (3015)

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

Event Date 11/26/2018

Event Type  malfunction  

Event Description

It was reported that a high output message was observed after increasing the patient's output current from 2.75 ma to 3ma with a m3000 programming system.The physician also said he saw a low output current message.Screen shots of the tablet verified that a output status warning indicator was observed when the patient was programmed to 2.75 ma but the output status was showing 3 ma.(indicating high output current.) screen shots of the tablet verified that a output status warning indicator was observed when the patient was programmed to 3 ma but the output status was showing 2.75 ma.(indicating low output current.).System diagnostics was not performed during this appointment.An internal data review of the generator identified no obvious issues.The device history records of the generator was reviewed and the device passed final quality and functional specifications prior to release.No further relevant information has been received to date.

Event Description

Through further review of the internal generator data and internal programming system logs, it was determined that the low/high output currents observed were a result of the generator comparing its programmed output current against a stale (out-of-date) value upon initial interrogation.This stale value, which represents the last output current delivered by the generator, appeared to not update as expected when it was purposely programmed higher or lower.The discrepancy in the programmed output current and the last output current caused the high/low output currents.Based on this information, the high / low output current message appears to be a false warning.It was noted that at the time where the high/low output current messages were observed, there were multiple communication failures that lead to interrupted programming sessions and programming events.No further relevant information has been receive to date.

Event Description

Review of the tablet log files and the generator tablet data identified that multiple programming attempts were made on this generator; however, some successful attempts did not appear successful to the m3000 tablet.It was noted that a programming command was sent to the tablet; however, there was no acknowledgement from the generator to the tablet in the log files that confirms that the programming event was successful.However it was clear that the generator's settings were successfully changed, as upon interrogation in the new session showed that the output currents were programmed to higher as intended.The same issue appeared to occur again when the physician tried to program the patient back down.The programmer is designed to immediately command the generator to perform stimulation at the new settings upon completion of a successful programming event to refresh the last output current delivered value.However in this case, as noted above, there were two cases where, although the programmer changed the generator's settings, the full programming event did not complete.As the tablet did not recognize that the programming events, the commands to initiate stimulation immediately at the new parameters were likely not provided to the generator.Therefore, the last output current delivered value was not refreshed.Data suggests that electromagnetic interference may have been the source of the programming issues that led to the interrupted communications based on the observation of numerous communication-related error codes.No further relevant information has been 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: 8186175
• MDR Text Key: 131155868
• Report Number: 1644487-2018-02364
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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
• Report Date: 03/14/2019

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
• Device Operator: Health Professional
• Device Model Number: MODEL 3000
• Device Lot Number: 4171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/07/2019; 02/18/2019
• Supplement Dates FDA Received: 02/01/2019; 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR