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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 250
Event Date 01/01/2009
Event Type  Malfunction  
Event Description

Rptr indicated they were having issues with their handheld computer. The device was sent to the manufacturer for analysis. Before analysis was completed info was found that the issue had previously been resolved with troubleshooting. Product analysis was later completed and found that the flashcard was missing a specific file that is meant to be installed on the handheld computer. Product analysis also found that the ac power adapter used to charge the handheld computer was damaged and unable to charge the device. When a known good ac power adapter was used, no other anomalies were identified with the handheld computer.

 
Manufacturer Narrative

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

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1375769
Report Number1644487-2009-00282
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/03/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/25/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number521402
OTHER Device ID Number7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/20/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/03/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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