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

Model Number	3000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	01/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device software version: version 1.0.
Event or Problem Description
Physician had been implanted with vns for more than six months and had been doing extremely well.Patient went six months seizure free with vns.But patient had breakthrough seizures on two consecutive days.The increased seizures are reported in mfr.Report # 1644487-2019-00362.Patient's generator was interrogated and the physician received 3 error messages.: generator at eos, not supplying stimulation, replace immediately, disabled due to error code 255 and high lead impedance.Patient was doing well for 6 months since implant and then had breakthrough seizures.Device was disabled and mom denies trauma to vns site.Ap neck and chest x-rays were reviewed.The generator was located in the patient¿s upper left chest.The connector pin could not be seen coming through the second connector block due to the angle of the image.Therefore complete pin insertion could not be verified in the images provided.The filter feedthru wires were confirmed to be intact.The cause of the reported high impedance could not be determined based on the images provided.Review of the tablet data identified that the end of service, high impedance and device not supplying stimulation messages may have been incorrectly displayed.It was determined that some response packets received from the generator via the wand were duplicated and/or received out of sequence compared to the prior command packets.The m3000 software does not validate the length of packets returned from the ipg via the wand.In these instances, this resulted in the software incorrectly calculating several parameter values or device status checks.This has manifested through incorrect/corrupted therapy parameter values, false high impedance warnings, and false eos statuses.While the root cause of these issues likely lies outside the m3000 software, validating the length of these packets would prevent such communication errors from propagating to the user interface and potentially resulting in the user to make misinformed decisions.Additional relevant information has not been received to date.
Event or Problem Description
Diagnostics were okay at the patient's follow-up appointment.No further relevant information 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: 8367848
• Report Number: 1644487-2019-00363
• Device Sequence Number: 2306754
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR