MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure of Device to Self-Test (2937)

Patient Problem Dysphasia (2195)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was having intolerable voice issues on an hourly basis.The patient¿s device was interrogated and found to be programmed to settings indicative of an interrupted system diagnostic test.The patient¿s device was tested during an office visit the previous day, but the system diagnostic test had to be interrupted because the test was too painful for the patient to tolerate.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 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: 3952700
• MDR Text Key: 4643606
• Report Number: 1644487-2014-01853
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• 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: 1063829
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR