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

Model Number MODEL 250

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 09/21/2015

Event Type  malfunction  

Event Description

It was reported that the physician's programming system was freezing when trying to interrogate patients recently.The physician tried to perform hard resets which did not resolve the issue.The physician indicated that this did not affect programming the patient's device as he was only trying to interrogate.So the patient's therapy was not affected.The physician was provided a new programming tablet.The handheld is expected to be returned for analysis, but has not been received to date.

Event Description

The handheld and flashcard were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the handheld was completed on 11/17/2015.The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry.Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis.Analysis of the flashcard was completed on 11/17/2015.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 5156461
• MDR Text Key: 28922767
• Report Number: 1644487-2015-06149
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MODEL 250
• Device Lot Number: 1075841
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1