MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Improper or Incorrect Procedure or Method (2017); Programming Issue (3014)

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

Event Date 09/23/2014

Event Type  malfunction  

Event Description

Clinic notes were received providing settings from a visit on (b)(6) 2015 and (b)(6) 2016.History in the notes indicated that the device may have been at settings indicative of a faulted diagnostics test with an off time of 60 seconds.Review of the manufacturer's in-house programming history revealed the last programmed settings also had an off time of 60 seconds from the date of (b)(6) 2014.The output current had been corrected by the physician in the same visit, but the off time had been left uncorrected at 60 seconds.The off time was adjusted to 1.1 seconds by the physician on (b)(6) 2016.Additional relevant information has not been received to-date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS; 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: 5688151
• MDR Text Key: 47305242
• Report Number: 1644487-2016-01166
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 1073773
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2012
• 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: 17 YR