MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 06/22/2014

Event Type  malfunction  

Event Description

It was reported that a medical professional was having issues with his programming system.The physician reported that he could not use his handheld computer unplugged from the outlet wall.It was reported that this occurred since 2 years ago.A frozen screen during the interrogation was also reported.Troubleshooting was performed without solving the issue.Review of manufacturing records confirmed that the handheld computer passed all functional tests prior to distribution.A wand and the suspected handheld computer were returned to the manufacturer on 07/06/2016.Analysis of the returned handheld computer is underway but it has not been completed to date.Analysis of the returned wand was completed and no visual or mechanical anomaly was identified.Continuity testing of the serial data cable and the battery cable passed.The programming wand performed according to functional specifications.

Event Description

An analysis was performed on the returned flashcard and handheld.The analysis results indicate that no anomalies associated with the handheld were noted during the testing using the ac adapter or the main battery with a full charge.Remaining battery charge level after >1-hr of testing was 16% of full capacity.The flashcard/software and the programming computer performed according to the specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5785227
• MDR Text Key: 50177235
• Report Number: 1644487-2016-01560
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 857133
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1