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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 12/01/2014
Event Type  Malfunction  
Event Description

Analysis of the handheld was completed on 01/05/2015. No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. Analysis of the flashcard was completed on 01/05/2015. An analysis of the handheld and flashcard software identified that the cyberonicsbu. Cdb database and 6 archive databases were corrupt. Further analysis identified that all the corrupt databases were 344kb in size, giving the indication that the archive databases are copies of the original corrupt cyberonics database. A root cause for file corruption could not be identified based on the available information. No further anomalies were identified.

 
Event Description

It was reported that the while attempting interrogations, the handheld device showed "vns therapy error. Error executing sql statement. " a hard reset was performed and the software flashcard was reseated; however, the issue did not resolve. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4367119
Report Number1644487-2014-03467
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/01/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1073772
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/10/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/10/2012
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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