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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Defective Device (2588); Device Displays Incorrect Message (2591)

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

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient's vns generator was unable to be interrogated using two different programming systems.It was reported that one of the programming systems showed the error message: "unable to interrogate with this version of software - error code 310".Troubleshooting was performed on both programming system by the company representative.The programming tablet usb cable was faulty and was replaced.The programming wand 9 volt battery was changed after what the wand was confirmed to be working.It was reported that the patient will be seen again in clinic to interrogate the generator.No generator issue is suspected.Return of the usb cable for analysis is expected, but it has not been received to date.

Event Description

The suspected usb cable was received by the manufacturer.An analysis was performed on the returned usb to db9 cable and the reported allegation was verified.The cause for the reported allegation is associated with two disconnected wire connections in the returned serial cable.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: 5629884
• MDR Text Key: 45288880
• Report Number: 1644487-2016-00946
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1