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	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Software version: (b)(6).
Event or Problem Description
It was reported by the physician that after performing system diagnostics, high impedance was reported.It was noted that the patient's device was checked with a software version (b)(6).The physician was instructed to bring the patient back and turn the normal and magnet mode output current to 0ma and re-run system diagnostics to verify this is not a true high impedance.Information was received from the physician confirming that there was false high impedance reading due to the software v (b)(6).Clinic notes received indicate that after programming the output current to 0ma, lead impedance was within normal limits.When the output current was programmed back on there was a false high impedance reading again.X-ray results were provided indicating that the lead and generator were in place with no noted disruptions.It was also stated that there was no evidence of compression fracture or spondylolisthesis.No additional relevant information has been received to date.
Additional Manufacturer Narrative
If remedial action initiated, check type, corrected data: initial report inadvertently did not select "notification".

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8965453
• Report Number: 1644487-2019-01723
• Device Sequence Number: 19463179
• Product Code: LYJ
• UDI-Device Identifier: 05425025750429
• UDI-Public: 05425025750429
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/01/2019

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: 08/14/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR