MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A company representative reported on (b)(4) 2016 a failure to interrogate a patient¿s generator prior to a replacement case.She then was unable to interrogate the new generator in the sterile pack.An "error establishing communication" message was observed.The tablet was not plugged in.The 9v battery in the programming wand was replaced, was tested and the power light stayed on 25 seconds.She reported that she had a white usb serial data cable connected to the tablet, and had a black usb serial data cable as back-up.She changed to the black cable.After the cable was replaced, and 15 seconds had elapsed, she selected, ¿interrogate device¿ and then, ¿start interrogation¿.As soon as she selected ¿start interrogation¿, an ¿error establishing communication¿ message appeared.She stated that she was able to successfully program a device using the white usb cable the day before.She then switched back to the white cable.She got the same result with the white cable.The company representative then used a programming tablet from a neurologist, and successfully interrogated/programmed the new generator.A replacement wand was sent to the company representative.It was later reported that the replacement wand had resolved the issue, however the company representative then discovered that her usb port in the programming tablet was damaged and causing communication errors.(reported in mfr report# 1644487-2016-02616).The wand and usb serial cable were received and analysis was performed.The reported failure to program was not identified with the programming wand.The programming wand performed according to functional specifications.Analysis was performed on the returned usb serial data cable.During the analysis, it was identified that a known good programming system was unable to establish communication with a known good generator using the returned usb serial data cable.The cause for the anomaly was associated with an open wire connection in the returned serial cable.Once the wire was soldered onto the usb serial data cable printed circuit board, no further anomalies were identified.Additional relevant information has not been received to-date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6149109
• MDR Text Key: 62190113
• Report Number: 1644487-2016-02802
• 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
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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: 10/24/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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: 35 YR