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

Model Number MODEL 250

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 12/01/2014

Event Type  malfunction  

Event Description

It was reported that the patient's device has not been able to be checked because the physician's handheld has not been working.Further follow-up with the physician identified that an error executing run app message was observed.Troubleshooting was performed by performing a hard reset, but the message did not resolve.The flashcard was removed and reinserted and the device was powered off and then back on; however, the same message was received.Another hard reset was performed and the issue did not resolve.No additional relevant information has been received to date.

Event Description

The handheld and flashcard are expected to be returned, but have not been received to date.

Event Description

An analysis was performed on the returned programming handheld and flashcard.No anomalies associated with flashcard software were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.During the analysis of the handheld, it was identified that the handheld was unable to load the vns version 8.1 software.The cause for the anomaly is associated with a bent pin in the flashcard slot.Once the pin was straightened, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.

Event Description

The handheld, flashcard, and programming wand were received for analysis.Analysis of the programming wand was completed on 02/27/2015.The programming wand performed according to functional specifications.Analysis of the handheld and flashcard are underway, but have not been completed to date.

Manufacturer Narrative

New information received corrects the suspect device.

• 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: 4417857
• MDR Text Key: 5378331
• Report Number: 1644487-2015-03610
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• 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: 1075847
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR