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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Loose or Intermittent Connection (1371)

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

Event Date 08/13/2014

Event Type  malfunction  

Event Description

It was initially reported that the usb cable adapter for the tablet was loose with normal uses.During a follow up visit, there was a failure to interrogate.The wand was checked and was exchanged but did not resolve the issue.Patient care was not impacted or affected as there was a backup system available.The usb cable adapters were returned to the manufacturer for evaluation.Product analysis is planned but has not been completed.There were two usb cable adapters that had this issue the other usb cable adapter is report on medwatch # 1644487-2014-02229.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution.

Event Description

Analysis of the usb cable was completed on 09/18/2014.No anomalies associated with the usb to db9 cable were noted during testing.The usb to db9 cable performed according to functional specifications.Attempts to obtain additional relevant information have been unsuccessful to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4062737
• MDR Text Key: 4737466
• Report Number: 1644487-2014-02228
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1