MAUDE Adverse Event Report: CYBERONICS INC PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Reset Problem (3019)

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

Event Date 06/17/2014

Event Type  malfunction  

Event Description

During review of the physician¿s handheld, it was observed that during interrogation on office visit on (b)(6) 2014 the patient's settings were different than what were programmed at the same office visit.The settings found were indicative of a generator diagnostics test which occurred on (b)(6) 2014.The device was not interrogated prior to the patient leaving the office on (b)(6) 2014 as recommended by device manufacturer to ensure the device is at the correct settings.No patient adverse events were reported.The physician reported that the settings will be corrected if the patient experiences an increase in seizures.

Manufacturer Narrative

Analysis of programming history.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 4006726
• MDR Text Key: 15122266
• Report Number: 1644487-2014-02014
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2014

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: 1077507
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/16/2014
• Initial Date FDA Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR