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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 06/15/2010
Event Type  Malfunction  
Event Description

Initial reporter indicated that their (b) (6) handheld computer is not turning on. It was reported that it had been plugged in overnight and the power light was green while plugged in. When the handheld was unplugged, the light turned orange. It was plugged back in and the light stayed orange. The handheld was returned for product analysis without the ac adapter and serial cable. Testing on the handheld showed it met specifications. At this time, the issue is believed to be with the ac adapter. Good faith attempts thus far have been unsuccessful in attaining that for product analysis.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058 201
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1760912
Report Number1644487-2010-01621
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/15/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/14/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number584959
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer06/17/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/15/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2008
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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