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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

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CYBERONICS, INC. PROGRAMMING WAND Back to Search Results
Model Number 201
Event Date 05/14/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld will not hold a charge. The physician reported that the handheld screen would "fade" shortly after being unplugged from the wall. The physician requested a new programming computer. The handheld and flashcard are expected to be returned for analysis, but have not been received to date.

 
Event Description

Additional information received revealed that the issue was actually with the programming wand not holding a charge, not the handheld computer. The site thought that charging the handheld device also charges the wand and did not realize the wand used a 9v battery. A company representative provided the physician¿s office training on how to replace the 9v battery and the site has not experienced any further issues. Nothing will be returned at this time as all the components of the programming system are functioning properly.

 
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Brand NamePROGRAMMING WAND
Type of DevicePROGRAMMING WAND
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3869933
Report Number1644487-2014-01486
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2014
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? Yes
Event Location Other
Date Manufacturer Received12/16/2014
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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