MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Loose or Intermittent Connection (1371); Device Inoperable (1663); Communication or Transmission Problem (2896)

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

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that the sales representative was at the physician's office and she was given a tablet that had a note dated (b)(6) 2016 that it was not working.There were a few other backup systems available so it didn't appear that any patient was affected at that time.There were intermittent communication problems which were confirmed.She tried to use the device to communicate with her demo device but could not get it to communicate despite troubleshooting.She confirmed that the wand was functioning properly with her tablet and checked the 9v battery.She also switched the serial cable which didn't resolve the communication issues and she noted that the usb port appeared loose despite the serial cable used.The tablet was received for analysis on 04/19/2016.Analysis is underway but has not been completed to date.

Event Description

Product analysis for the returned tablet was completed and approved on (b)(6) 2016.An analysis was performed on the returned tablet and the reported allegation was verified.During the analysis, it was identified that the usb port was damaged and could not be used during testing.As a result, the tablet was unable to establish communication.No further anomalies were identified.

• Brand Name: PROGRAMMING COMPUTER
• 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: 5644342
• MDR Text Key: 46213272
• Report Number: 1644487-2016-00988
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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