MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/30/2014

Event Type  No Answer Provided  

Event Description

This report is to correct the initial mfr.Report that was inadvertently sent with a duplicate report #.The report was submitted via emdr on 08/21/2014 regarding a handheld screen issue and was inadvertenly sent with report # 1644487-2014-02046.Please correct that initial report to reflect the new number attached to this follow-up report.

Event Description

The handheld and flashcard were received for analysis.Analysis of the handheld was completed on (b)(4) 2014.No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.Analysis of the flashcard was completed on (b)(4) 2014.No anomalies associated with flashcard software were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Manufacturer Narrative

This report is to correct the mfr.Report # of the initial mfr.Report.

Event Description

It was reported that during the pt's office visit that the pt's magnet activations were not displaying correctly.It was reported that the pt only had one magnet swipe recently, with only a total of 8 registering.However, for the one activation on (b)(6) 2014, the tablet magnet history was displaying 15 times.The total swipes registered displayed as 86.A copy of the physician's programming tablet data was obtained.Magnet history coincides with only one swipe registering on (b)(6) 2014 with no indication of multiple magnet activations.It was observed that total operating time rollover of the device occurred between the last appointment on (b)(6) 2012 and (b)(6) 2014.As a result, the magnet history on the tablet was showing 15 activations on (b)(6) 2014, because no other activations were available in the history due to rollover.The 15 most recent magnet activations stored within the generators memory span the time period before/after the rollover event are displayed and since there was only one swipe, 15 activations were displayed on the tablet on (b)(6) 2014.It is known that the device reed switch can be activated by several consumer devices/other devices that have magnetic field (i.E.Multiple accidental magnet swipes, etc.).However, attempts for further info from the physician were unsuccessful.

Manufacturer Narrative

Electronic submission of this report was not possible due to a problem with the mfr's software used for emdr submissions.Method: review of programming history performed.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 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: 4027546
• MDR Text Key: 4729623
• Report Number: 1644487-2014-02070
• 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: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• 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: 1185729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR