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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 10/03/2012
Event Type  Malfunction  
Event Description

Additional analysis was performed on the returned ac adapter. The returned ac adapter was opened to perform a visual inspection of the internal components and printed circuit board. Results of the visual inspection identified no anomalies. No further analysis could be performed as this is a non-cyberonics manufactured product and no additional product information is available.

 
Event Description

Reporter indicated a vns dell x50 computer would not power on. The computer used to power on but would take 10-15 minutes to do so. Now, it does not power up at all. A hard reset of the computer did not resolve the issue, and it was confirmed the "lock" button was not engaged. The computer, flashcard, and programming wand were returned for analysis. No anomalies were noted with the programming wand or flashcard. No anomalies associated with the main battery of the computer were identified during the analysis. During the analysis it was identified that the returned ac adapter was defective and unable to power the returned handheld. The cause for the anomaly is associated with an incompatible (underrated) ac adapter. No further anomalies were identified.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2804113
Report Number1644487-2012-02722
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/25/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number874817
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/05/2012
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/25/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/06/2012
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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