MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Computer Software Problem (1112)

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

Event Date 04/20/2015

Event Type  malfunction  

Event Description

An analysis was performed on the returned flashcard and no anomalies associated with the vns software were identified.During the analysis it was identified that the vns software would not load into the handheld.The cause for the identified anomaly is associated with a defective flashcard.No further anomalies were identified.An analysis was performed on the handheld and no anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

It was reported that the physician¿s handheld computer did not install the vns programming software.The medical professional indicated that the handheld computer displayed the operating system¿s screen despite attempting a hard reset.It was reported that the vns software flashcard was properly inserted in its compartment of the handheld computer.The software flashcard and the handheld computer have been returned to the manufacturer.Analysis is underway but it has not been completed to date.

Manufacturer Narrative

Event Description

An analysis was performed on the returned serial cable and no anomalies associated with the serial cable were noted.The serial cable performed according to functional specifications.

Event Description

The flashcard was sent to the manufacturer and the cause for the anomaly is associated with a damaged connector pin.No other anomalies were identified.

• 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: 4773717
• MDR Text Key: 5941273
• Report Number: 1644487-2015-04688
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2015

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: 1063528
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/15/2015; 07/16/2015; 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1