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

Model Number MODEL 250

Device Problems False Alarm (1013); Operating System Version or Upgrade Problem (2997)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the physician's software upgrade, an invalid password error message was received when the correct password was used.The device was powered down and back on with no success.The physician was provided a new programming tablet and the old tablet was returned for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the tablet was completed on (b)(6) 2015.An analysis was performed on the returned tablet and a likely cause for the reported complaint was identified.During the analysis, it was identified that the tablet bios would not accept the standard bios password.The most likely cause for the anomaly is associated with a non-standard bios password being set inadvertently into the tablet bios.Once the incorrect bios was cleared, no anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.

• 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: 5289671
• MDR Text Key: 33960132
• Report Number: 1644487-2015-06702
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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