MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Computer Software Problem (1112); Programming Issue (3014)

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

Event Type  malfunction  

Event Description

A computer software error has been verified, on (b)(6) 2015 for the patient¿s model 102 generator from a review of the april programming history database spreadsheet and periodic review algorithm.On (b)(6) 2007 the device was interrogated then programmed, then a system diagnostic was performed.After the system diagnostic the device was interrogated, programmed and a final interrogation the settings were as intended.There is no evidence of a "faulted" diagnostic or communication interruption during this visit.On the next recorded visit (b)(6) 2014 the first interrogation the settings were indicative of a "faulted" diagnostic.There is approximately 7 years of missing programming history and the date of the "faulted" diagnostic is unknown.

Event Description

The physician's programmer data was copied and received by the manufacturer.However, the received copied data does not provide additional programming data for this patient's generator.

• 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: 4892758
• MDR Text Key: 6024075
• Report Number: 1644487-2015-05090
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1