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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Loose or Intermittent Connection (1371); Device Inoperable (1663)

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

Event Date 03/25/2014

Event Type  malfunction  

Event Description

It was reported that the neurologist¿s handheld device was not working and was unable to interrogate the patient¿s generator.Follow-up confirmed that the handheld device was functioning and successfully communicated with the patient¿s generator.It was noted during follow-up that the handheld device¿s serial cable was loose and had to be securely held for successful interrogation.

Event Description

Additional information was received indicating that there were no issues with the programming system.The handheld device was able to successfully interrogate a demonstration device multiple times.The serial cable was not loose but was provided to the neurologist as a possible cause of communication issues for troubleshooting purposes.The programming system was stored plugged into an outlet and placed in a drawer.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.Serial #, lot #, other, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Name and address, fax #, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Manufacture date, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 3763969
• MDR Text Key: 4420544
• Report Number: 1644487-2014-01083
• 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,Followup
• Report Date: 03/26/2014

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: 1075856
• 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: 04/23/2014
• Initial Date FDA Received: 04/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR