MAUDE Adverse Event Report: CYBERONICS INC PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Programming Issue (3014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2012

Event Type  malfunction  

Event Description

During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2010 the patient's settings were different than what were programmed at the same office visit.The settings found were indicative of a generator diagnostic test which occurred on (b)(6) 2010.The physician corrected the settings; however, the magnet on time was not corrected.No patient adverse events were reported.

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: 3548778
• MDR Text Key: 17151339
• Report Number: 1644487-2014-00028
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• 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: 584958
• Other Device ID Number: VERSION 7.1
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 12/06/2013
• 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