MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/20/2014

Event Type  malfunction  

Event Description

Follow up showed that no other issues were encountered with the handheld device or software, and no other issues had been reported since.The handheld device is not expected for return.Based on the sequence of events, the issue appears to be due to incomplete insertion of the flashcard into the handheld device as this is expected behavior if no flashcard is inserted.

Event Description

It was reported that the patient's handheld was not allowing the "database utilities" option to be selected when attempting to backup the data.Troubleshooting was performed; however, the data could not be successfully transferred to a blank flashcard.No patient's were affected by this issue.The handheld is expected to be returned for analysis, but has not been received to date.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr indicated that the suspected device is expected for return, but it is not expected for return.Type of device, name, corrected data: previously submitted mdr indicated that the suspect device is the handheld device, but it was the software.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4330577
• MDR Text Key: 5169506
• Report Number: 1644487-2014-03319
• 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,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• 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 8.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1