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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 08/27/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's new programming tablet would not power on when pressing the power button. It was reported that the power button was illuminated green when pressed. It was reported that within a few seconds of pressing the button the green light would disappear. This was attempted multiple times with no result. The tablet was left plugged into the electrical outlet for a few minutes and when it was attempted to power on again it did not power on. A new programming tablet was provided to the physician. The non-functioning tablet was received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the tablet was completed on 10/02/2014. The cause for the complaint is associated with a defective motherboard. Once the board was replaced, no further anomalies associated with the tablet were identified during the analysis.

 
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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 Key4115781
Report Number1644487-2014-02462
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 10.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/05/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/02/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/28/2014
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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