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

Model Number MODEL 250

Device Problems Difficult to Interrogate (1331); Communication or Transmission Problem (2896)

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

Event Date 10/05/2016

Event Type  malfunction  

Event Description

It was reported that the medical professional was having difficulties to interrogate generators when using his handheld computer.It was reported that the device which is very old, does not communicate anymore with generators.Review of manufacturing records confirmed that the programming computer passed all functional tests prior to distribution.The suspected programming computer was returned to the manufacturer on 10/13/2016.Analysis is underway but it has not been completed to date.

Event Description

Analysis of the returned flashcard was completed 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 of the returned handheld computer was completed and the reported allegation was not verified.No anomalies associated with the handheld 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: 6050205
• MDR Text Key: 58526525
• Report Number: 1644487-2016-02445
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/05/2016

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: 874811
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1