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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 MODEL 250
Event Date 12/08/2011
Event Type  Malfunction  
Event Description

While a physician was reviewing a patient's magnet activation history on the handheld computer, it was observed that the magnet activations were occurring at odd times and displayed in an upside down pyramid formation. Good faith attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

Analysis of magnet activation history performed.

 
Event Description

Copies of the flashcards belonging to the physician were received and the magnet activation history for each of the flashcards were reviewed however none of the data provided matched the information provided at the time of the initial report. Additionally multiple generators showed magnet activations from (b)(6) 2011, so it is unknown which generator was the one with the magnet activation display issue.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2479663
Report Number1644487-2012-00603
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/05/2012
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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