MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)

Patient Problems Therapeutic Response, Decreased (2271); Depression (2361)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was experiencing an increase in depression that was not above pre-vns baseline levels.The psychiatrist stated that at the patient last office visit on (b)(6) 2014, the patient¿s device was found to be disabled.It was determined that the psychiatrist performed a generator diagnostic test during an office visit on (b)(6) 2014 which disabled the patient¿s device and likely caused the patient¿s increase in depression.The psychiatrist stated that he was not very familiar with the device and had programmed the patient¿s device back on when he discovered that it was disabled.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 3966926
• MDR Text Key: 4747824
• Report Number: 1644487-2014-01889
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 07/07/2014

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
• Device Lot Number: 1075849
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR