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

Model Number MODEL 250

Device Problems Device Inoperable (1663); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

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

Event Date 01/20/2015

Event Type  malfunction  

Event Description

It was reported that the physician's handheld was broken and had not worked in some time.The handheld has been kept in the office in the box unused.There were other programming systems available so no patient care was interrupted.The handheld and tablet were received for analysis.Analysis of the handheld was completed on (b)(4) 2015.During the analysis it was identified that the handheld was unable to advance past the screen alignment utility.The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry.No further anomalies associated with the handheld performance were identified during the analysis.Analysis of the flashcard was completed on (b)(4) 2015.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

• 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: 4521867
• MDR Text Key: 5404734
• Report Number: 1644487-2015-03870
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• 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: 1073772
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1