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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/22/2015

Event Type  malfunction  

Event Description

It was reported that the patient's generator was unable to be interrogated and that three months prior was "fine".It was reported that the physician's handheld was not plugged into the wall during interrogation.The 9v batteries were confirmed to be working properly.It was unknown whether or not the patient could feel device stimulation as the patient is non-verbal.A battery life calculation was performed which did not show suspected end of service.A company representative went to the physician's office to troubleshoot the patient's device and found that the physician's tablet usb cable was the issue.Once the usb cable was replaced the patient was able to be interrogated successfully.The faulty usb cable is expected to be returned for analysis, but has not been received to date.

Event Description

The usb cable was received for analysis.Analysis was completed on 11/30/2015.Analysis identified two disconnected wire connections in the returned serial cable.Once the wires were soldered onto the serial cable pcb, no further anomalies were identified.

Manufacturer Narrative

(b)(4).This information was inadvertently left off of supplemental mfr report #01.

• 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: 5226737
• MDR Text Key: 31572174
• Report Number: 1644487-2015-06455
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/18/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/09/2015; 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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: 8 YR