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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 01/16/2014
Event Type  Malfunction  
Event Description

Additional information was received stating that the programming wand's 9v battery was depleted and caused the reported event.

 
Event Description

The physician reported that the handheld showed the following error message: "error initiating programming" when he tried to interrogate the patient's vns generator.

 
Manufacturer Narrative

Brand name, corrected data: supplemental report #1 did not update the product to the programming wand. The product has been updated in this report. Type of device, name, corrected data: supplemental report #1 did not update the product to the programming wand. The product has been updated in this report. Model #, corrected data: supplemental report #1 did not update the product to the programming wand. The product has been updated in this report. Operator of device, corrected data: supplemental report #1 did not update the product to the programming wand and therefore the user would be the physician. The operator of the device has been updated in this report.

 
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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 Key3630089
Report Number1644487-2014-00428
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2014
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 Received04/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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