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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 01/01/2008
Event Type  Malfunction  
Event Description

It was reported that a (b) (4) handheld was displaying multiple time values on the magnet activation display. No functional deficiencies were reported. Good faith attempts to obtain additional information and product for further analysis have been unsuccessful to date.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1134886
Report Number1644487-2008-01940
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/24/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/24/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2008
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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