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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 08/01/2014
Event Type  Malfunction  
Event Description

Analysis of the tablet was completed on 12/03/2014. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery. The cause for the identified anomaly is associated with a loose battery cable to the motherboard. Once the cable was reseated, no further anomalies were identified during the analysis. Visual analysis also identified damage to the back cover of the tablet. The cause of the damage could not be identified during the analysis.

 
Event Description

The programming tablet was received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

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

 
Event Description

A company representative's programming tablet has been shutting off and will only stay operational if the device is plugged directly into the electrical outlet. The battery status indicator shows 100% charged and the battery status button illuminates red lights when charging as expected. When the tablet is disconnected the tablet powers down. The company representative was provided a new programming tablet. The non-functional tablet is expected to be returned for analysis, but has not been received to date.

 
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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 Key4116009
Report Number1644487-2014-02466
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/27/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 10.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/03/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/03/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/10/2013
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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