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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Failure to Advance (2524)

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

Event Date 06/18/2015

Event Type  malfunction  

Event Description

It was reported that the programming wand was malfunctioning and was unable to perform interrogations.The 9v batteries had been previously replaced in both programming wands prior to the reported event and the green light was confirmed to stay on for longer than 25 seconds.The handheld device was unplugged when performing the interrogations and the connections between the programming system components were secure.The interrogations only occur in two rooms in the clinic and interrogations in these rooms have been previous successful; therefore, emi was not suspected to be the issue.The programming system was returned to the manufacturer for analysis.The programming wand and software flashcard performed according to functional specifications.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.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5151299
• MDR Text Key: 28707237
• Report Number: 1644487-2015-06126
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 10/07/2015

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
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 1063824
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1