MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

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

Event Date 08/26/2014

Event Type  malfunction  

Event Description

Analysis of the handheld device and software flashcard was completed.The cause for the reported event is associated with the flashcard memory being corrupt.A root cause for the memory corruption could not be determined based on the available information.Once the memory was formatted and new installation software was copied onto the flashcard, no further anomalies associated with flashcard performance were identified.The handheld performed according to functional specifications.

Manufacturer Narrative

Follow-up type/additional manufacturer narrative and/or corrected data; correct data: supplemental mdr #02 inadvertently did not indicate and describe the correction information below.Device manufacture date; corrected data: supplemental mdr #01 inadvertently did not provide the manufacturer date for the suspected software flashcard.The corrected data was provided in supplemental mdr #02.

Event Description

The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

Event Description

It was reported that the physician¿s handheld device was not pulling up patient data.Follow-up clarified that the when the handheld device was powered on, the programming software would not load.The software flashcard was reinserted, but the issue did not resolve.The handheld device and software flashcard have not been returned to date.

• 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: 4111476
• MDR Text Key: 5258023
• Report Number: 1644487-2014-02432
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/26/2014

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: 1075849
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2014; 12/16/2014; 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1