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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 08/11/2014
Event Type  Malfunction  
Event Description

It was reported that the handheld device was not working properly. The handheld was returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned handheld device and software flashcard was completed. It was identified that the handheld was received with the lock button in the locked position. Since the lock button was locked, the handheld buttons and touchscreen were unresponsive. Once the lock button was moved to the unlocked position no anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
Manufacturer Narrative

Name and address, title, first name, last name, address, zip/postal, phone #; corrected data: the previously submitted mdr provided the wrong initial reporter. Occupation; corrected data: the previously submitted mdr provided the wrong initial reporter. Initial reporter also sent report to fda; corrected data: the previously submitted mdr provided the wrong initial reporter. It is unknown if the reporter also reported the event to fda.

 
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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 Key4077155
Report Number1644487-2014-02293
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1063824
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/12/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/29/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2012
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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