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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 08/27/2008
Event Type  Malfunction  
Event Description

It was reported that the physician had difficulty interrogating the pt's device during a routine programming session. The physician performed troubleshooting and was unable to resolve the issue. The site has had similar problems in the past when they used the same wand with different handheld devices on various pts. Good faith attempts to obtain additional info and product for analysis have been unsuccessful to date.

 
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Brand NamePROGRAMMING WAND
Type of DeviceNONE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd
ste 600
houston , TX 77058
2812287200
MDR Report Key1181597
Report Number1644487-2008-02300
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/27/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2008
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? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/27/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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