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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 06/20/2012
Event Type  Malfunction  
Event Description

It was reported by a company representative that a physician's handheld computer no longer worked. Additionally, the area representative indicated he used his programming wand with the reported handheld and communication was unsuccessful with a vns patient. The reported handheld was returned to the manufacturer and at the moment remains under analysis.

 
Event Description

An analysis was performed on the returned handheld. During the analysis it was identified that the ac adapter was defective and could no longer power the handheld. No further anomalies associated with the handheld performance were noted during testing using a known good ac adapter or the main battery with a full charge. When analysis of the software was performed it was identified that the flashcard contained a non-vns file and non-vns folders. The file and folders were created as a result of the flashcard being inserted into a (b)(6) computer. The file and folders had no impact on the vns and flashcard performance. 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

 
Manufacturer Narrative

Device malfunction 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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2653531
Report Number1644487-2012-01760
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number874822
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/02/2012
Is The Reporter A Health Professional? No
Distributor Facility Aware Date07/25/2012
Event Location Other
Date Manufacturer Received07/25/2012
Was Device Evaluated By Manufacturer? Yes
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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