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

Model Number MODEL 250

Device Problems Failure to Charge (1085); Device Operates Differently Than Expected (2913)

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

Event Date 10/04/2016

Event Type  malfunction  

Event Description

It was reported that physician experienced technical difficulties with the programming system.Further information was received that the handheld battery did not keep the charge, besides, the handheld serial cable was suspected to be faulty.The programming wand was checked, battery changed and the wand confirmed to be working fine.Additional information was received the programming computer remains plugged into the wall when not in use because the battery doesn't hold it.It was reported that the physician sometimes has to use the programming computer plugged into the mains.Review of manufacturing records confirmed all tests passed for the device prior to distribution.

Event Description

An analysis was performed on the returned flashcard and no anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.An analysis was performed on the returned handheld and the reported allegation of the handheld not keeping charge was not verified.No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 6059763
• MDR Text Key: 58616510
• Report Number: 1644487-2016-02473
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

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: 857133
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1