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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 01/13/2009
Event Type  Malfunction  
Event Description

Reporter indicated that there was an issue with the handheld computer that was resulting in the magnet activations screen showing multiple results per line, when only 1 result per line should be present. The product has been returned to the mfr, but analysis of the device is not yet completed.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058-2017
2812287200
MDR Report Key1371443
Report Number1644487-2009-00256
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/13/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number584954
OTHER Device ID Number7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/23/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/13/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2008
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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