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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 07/23/2014
Event Type  Malfunction  
Event Description

It was reported that the physician assistant's handheld had a dark screen. The power button was pressed which illuminated the screen briefly, but the handheld screen returned dark. During troubleshooting the company representative identified that the handheld did not show small icons on the bottom of the database screen. The physician assistant was provided a new programming tablet. The handheld is expected to be returned, but has not been received to date.

 
Event Description

This event is a known issue with software version 8. 0 and rior model 250 software, and v10. 0 software is the same software as v8. 0 on a tablet interface. This issue has been corrected with v8. 1 software. In these events, multiple magnet activation times being displayed on the same line when viewing patient magnet history with vns programming software. The issue is related to a local array being mis-declared as a static variable within the programming software which is triggered when viewing patient magnet activation history which spans the time period before and after a generator total operating time rollover.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
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 Key4027185
Report Number1644487-2014-02046
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial,Followup
Report Date 07/23/2014
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 Number1077282
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/21/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/26/2011
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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