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

Model Number MODEL 250

Device Problems Radio Signal Problem (1511); Device Displays Incorrect Message (2591); Operating System Version or Upgrade Problem (2997)

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

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

Udi for suspect device: (b)(4).

Event Description

It was reported on (b)(6) 2015 there was an issue with the upgrade of the physician's tablet.It was stated that the physician was unable to get a signal from the patients device.It was noted that the tablet gets an error message at first but it usually works eventually.The patient's device was able to be interrogated with another device.Follow-up showed that this nurse's tablet that was upgraded was used with a different wand and still the same message, unable to establish connection, retry positioning wand was seen.Further trouble shooting showed that the issue was isolated to a faulty serial cable.The faulty serial cable was returned for analysis on 08/28/2015.Analysis is underway but has not been completed to date.

Event Description

Product analysis was completed and approved on (b)(6) 2015.An analysis was performed on the returned usb to db9 cable and a device failure was confirmed.Two disconnected wire connections in the returned serial cable were found.Once the wires were soldered onto the serial cable pcb, no further anomalies were identified.

• 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: 5064688
• MDR Text Key: 25936309
• Report Number: 1644487-2015-05737
• 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
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• 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 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2014
• 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