MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Failure to Align (2522); Operating System Becomes Nonfunctional (2996)

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

Event Date 06/02/2015

Event Type  malfunction  

Event Description

It was reported handheld computer was no longer working, and a new programming system was requested by the physician.A replacement system was provided.It was reported that the handheld device was freezing upon interrogation.Mfg report # 1644487-2015-04958 captures a subsequent screen alignment issue.The software has been received by the manufacturer for analysis.However, analysis has not been completed to date.

Event Description

Product analysis for the software 250-8.1 was completed and approved on (b)(6) 2015.An analysis was performed on the returned flashcard and showed that no anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 4872678
• MDR Text Key: 6047547
• Report Number: 1644487-2015-05037
• 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,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• 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: 1063825
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1