MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Loss of Power (1475); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/11/2011

Event Type  malfunction  

Event Description

It was reported that the neurologist accidently turned off the patient¿s vns device about 3.5 to 4 years ago.The patient¿s vns has not been treated since and has reportedly been left off since that time.The manufacturer review of the manufacturer¿s in-house programming database revealed that on (b)(6) 2011, a system diagnostic test was performed but faulted (did not complete).A final interrogation was not performed prior to the patient leaving the clinic as recommended in manufacturer labeling.Faulted system diagnostic tests can result in programming anomalies in which programming settings are changed to unintended parameters.Good faith attempts for additional programming history is underway, but there is no relevant information to date to confirm this event.

Manufacturer Narrative

Review of programming history performed.Software and user error is suspected to have caused the event.

Event Description

Attempts for programming history were not performed.There is information available that provides that this was likely the date of the programming anomaly.

Manufacturer Narrative

Describe event or problem, corrected data: the initial report inadvertently reported that good faith attempts for additional programming history was underway.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 4237887
• MDR Text Key: 5076926
• Report Number: 1644487-2014-02973
• 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: Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

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: 840144
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 11/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR