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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
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.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING 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 Key4027546
Report Number1644487-2014-02070
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/25/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1185729
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/14/2014
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/14/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/12/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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