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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND NONE

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CYBERONICS, INC. PROGRAMMING WAND NONE Back to Search Results
Model Number 201
Event Date 08/01/2008
Event Type  Malfunction  
Event Description

Reporter indicated that site was having problems with the communication between their handheld computer and the interrogating wand. Manufacturer rep tested the system and found it to be the wand that was not working properly. Product has been returned to manufacturer, but product analysis is pending.

 
Manufacturer Narrative

Device malfunction is supected, but did not cause or contribute to a death or serious injury.

 
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Brand NamePROGRAMMING WAND
Type of DeviceNONE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd. ste 600
houston , TX 77058
2812287200
MDR Report Key1181365
Report Number1644487-2008-02144
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/25/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number201
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/02/2008
Is The Reporter A Health Professional? No
Date Manufacturer Received08/25/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2005
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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