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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 08/26/2014
Event Type  Malfunction  
Event Description

It was reported that there was physical damage to the physician¿s programming tablet that occurred on (b)(6) 2014. It was reported that the usb cable for the programming wand would not connect to the tablet usb port due to the port being bent. It was reported that no patient's were affected because another programming system was available. It was reported that the tablet was used the day prior without any difficulty and placed back in locked storage after use. It is unknown if any mishandling occurred. A new programming tablet was provided to the physician. The tablet was received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the programming tablet was completed on (b)(6) 2014. During the analysis, it was identified that the usb port was damaged. As a result, the tablet was unable to establish communication and generating port error messages. No further anomalies were identified.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the programming tablet confirmed all quality tests were passed prior to distribution.

 
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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 Key4115931
Report Number1644487-2014-02465
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,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 HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 10.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/02/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/25/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2013
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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