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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 03/05/2015
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld would not power on after being plugged into an electrical outlet for approximately 10 minutes. It was reported that the power light illuminated orange indicating that there was power to the handheld. A hard reset was performed which did not resolve the issue. The handheld was left plugged to the power outlet for a while longer and then troubleshooting was again attempted. The handheld would still not power on so the physician was provided a new programming computer. The handheld and flashcard were received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Product analysis was completed for the handheld device on 04/20/2015. The cause for the failure to power on is associated with a defective main board. Once the board was replaced, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. Product analysis was completed for the software flashcard on 04/20/2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

 
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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 Key4641640
Report Number1644487-2015-04295
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1073772
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/26/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/18/2006
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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