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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 09/11/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld would not load the vns software. Hard resets were performed and the battery was removed and replaced. The flashcard was removed and the pins were inspected and appeared to be fine. The flashcard was reinserted and the software would still not load. It was reported that the handheld was last used approximately two weeks prior. Another programming computer was available so no patient's were affected. A new programming computer was provided to the physician. The handheld is expected to be returned for analysis, but has not been received to date.

 
Event Description

Analysis of the flashcard was completed on 02/06/2015. The cause for the allegation is associated with a missing 2577 folder that contained the vns v8. 1 installation files. A cause for the missing folder could not be identified during the analysis. No further anomalies were identified. Analysis of the handheld was completed on 02/06/2015. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications.

 
Manufacturer Narrative

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

 
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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 Key4163793
Report Number1644487-2014-02627
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075856
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/14/2013
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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