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

Model Number MODEL 250

Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)

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

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a field clinical engineer was having trouble interrogating a patient in the operating room.The manufacturer's clinical engineer performed troubleshooting on the programming system and verified there were tight connections between the programming wand and the serial cable, the tablet was not plugged in, the wand had sufficient battery, and there was limited emi in the room.The generator was removed from the patient's pocket and interrogation was still unsuccessful.A hard reset on the tablet was performed and the communication issues then resolved.Later in the day, after the hard reset, the nurse stated that there were issues with the tablet's touch screen.The touch screen display was reportedly not lined up correctly.A tablet calibration was then performed and the issues reportedly resolved.The sales representative provided later follow-up stating that there were still tablet screen issues occurring a month later and these issues could not be resolved through resets or troubleshooting.The tablet has not been received by the manufacturer to date.No further relevant information has been received to date.

Event Description

The tablet was returned without the rf adapter, the usb serial adapter, or the power supply.The tablet was analyzed and the reported issue could not be re-created in the product analysis lab.No anomalies were identified with the analysis of the tablet and the tablet was able to perform according to all 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: 5973058
• MDR Text Key: 55722820
• Report Number: 1644487-2016-02172
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

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: Other
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0.4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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
• Patient Age: 47 YR