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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

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CYBERONICS PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Event Date 09/05/2011
Event Type  Malfunction  
Event Description

During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2011 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2011. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2011. The physician corrected some settings; however, the device pulse width, off time, magnet output current and magnet on time were not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2011 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct these settings back to previous settings. No patient adverse events were reported.

 
Manufacturer Narrative

Analysis of programming history.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
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 Key4063976
Report Number1644487-2014-02259
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/05/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number840999
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/08/2010
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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