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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 08/18/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld was having intermittent trouble and that it would sometimes interrogate patient's generators and sometimes it would not. Additionally, it was reported that occasionally device diagnostics would not complete. A known working wand was connected to the handheld and the problem persisted indicating a possible handheld or handheld serial cable issue. It was reported that the message "failure to receive all bytes in sequence message" was seen. The physician has several programming systems and no patient's were affected by this issue. A new serial cable was provided to the physician. No additional relevant information has been received to date. The serial cable is expected to be returned for analysis, but has not been received to date.

 
Event Description

Additional information was received indicating that the replacement serial cable had solved the reported programming issues. The suspect serial cable was lost; therefore, no analysis can be performed.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
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 Key4089126
Report Number1644487-2014-02340
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/15/2014
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 Received01/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/19/2007
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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