MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number	MODEL 250
Medical Device Problem Code	Programming Issue (3014)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician has been having intermittent programming issues with his programming system on (b)(6) 2016.The nurse didn't know what error messages were observed.She called to report the issues after the event and didn't have the programmer with her, so no troubleshooting could be performed on the phone.Additional information was received from a company representative that the serial cable on the tablet was replaced on (b)(6) 2016 and the programming system is now working fine.Per the company representative, the wand did have a good battery and the power lights stayed on for 25 seconds.The company representative tried removing the old white serial cable and reconnecting it after waiting for 15 seconds and attempted interrogation but it did not work.Therefore, the old white serial cable was replaced with a new black serial cable and the programming system then worked.No patients were affected.The serial cable does not require return, as the failure mode is understood to be a failure of the serial cable associated with a disconnected wire connection.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 5884186
• Report Number: 1644487-2016-01859
• Device Sequence Number: 430056
• Product Code: LYJ
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 08/03/2016

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 250
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2016
• Initial Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1