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

Model Number MODEL 250

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/01/2015

Event Type  malfunction  

Event Description

The handheld computer and the software flashcard were received by the manufacturer.Analysis is underway but it has not been completed to date.Review of manufacturing records confirmed that the handheld passed all functional tests prior to distribution.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld passed all functional tests prior to distribution.

Event Description

An analysis on the returned handheld confirmed that there were no anomalies associated with the main battery.During the analysis it was identified that the handheld was returned without a battery cover.As a result, the handheld would not power on.Once a known battery cover was installed, the handheld performed according to functional specifications.No anomalies associated with the flashcard software or databases were identified during analysis of the returned flashcard.

Event Description

It was reported that the physician's handheld does not respond to charging or hard resetting.The physician was provided a new programming computer.The handheld is expected to be returned for analysis, but has not been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 4733491
• MDR Text Key: 5866277
• Report Number: 1644487-2015-04580
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2015

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: 06/19/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 04/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/30/2015; 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1