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

Model Number MODEL 250

Device Problems Loose or Intermittent Connection (1371); Invalid Sensing (2293); Communication or Transmission Problem (2896)

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

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a company representative's tablet was having trouble doing heartbeat detection during at least three surgeries.She was able to interrogate and do diagnostics in each case without issue, but she could not do the heartbeat verification because it would just keep going and going without any heartbeat shown.She had not tried doing heartbeat verification outside of the operating room.In each case, she switched out her tablet for the surgeon's but kept the same serial cable and wand, and there were no issues with the heartbeat detection with the surgeon's tablet.Further information was received indicating that she had tried moving to different areas of the operating room, but the heartbeat verification did not work.She did report that the serial cable felt loose inside the usb port of the tablet.The company representative attended another surgery on (b)(6) 2016, and she was unable to communicate with the patient's generator at all.She was holding the serial cable in the tablet tightly and moved the tablet away from the operating table as far as possible, but she was still unable to communicate with the generator.Once the patient was in post-op, she was able to communicate with the patient's generator and perform heartbeat verification, using the same programming system, without any problems.During another surgery around (b)(6) 2016, the company representative was unable to communicate with another generator.She then switched out her serial cable and wand with known good ones, and she still was unable to communicate with the generator.Then, after the surgery was complete, her programming system was able to communicate with the patient's generator in post-op without issue.A new tablet was then provided to the company representative because the tablet had been identified as the most likely cause of the communication issues.The faulty tablet has not been received to date.

Event Description

The tablet was received, and analysis was approved.No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.

• 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: 6029169
• MDR Text Key: 57568724
• Report Number: 1644487-2016-02361
• 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: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• 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 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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