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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Defective Device (2588); Communication or Transmission Problem (2896)

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

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported than a medical professional could not interrogate generators when using her programming system.Troubleshooting was performed and the connection of the usb cable to the tablet was suspected to be at fault.Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution.The suspected usb cable was returned to the manufacturer.Analysis is underway but it has not been completed to date.

Event Description

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 a disconnected wire connection in the returned serial cable.Once the wire was 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: 5853315
• MDR Text Key: 52061397
• Report Number: 1644487-2016-01774
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Assistant
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• 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: 07/22/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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