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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 01/14/2014
Event Type  Malfunction  
Event Description

On (b)(6) 2014, it was reported that the physician's handheld was showing an error that the flashcard is unable to be recognized. A hard reset was performed, but the error showed up right after the dell screen. The flashcard was removed, and it was observed that a few of the pins in the flashcard slot were visibly bent. Attempts have been made for additional information; however, they were unsuccessful. No other information has been provided.

 
Manufacturer Narrative

 
Event Description

The physician's office reported that they no longer have the handheld device, and the location/disposition of the device is unknown.

 
Manufacturer Narrative

Manufacturer reviewed device history records. Review of the handheld device history records confirmed all quality specifications were passed prior to distribution.

 
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Brand NamePROGRAMMING COMPUTER
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 Key3623251
Report Number1644487-2014-00389
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/11/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075834
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/25/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/19/2012
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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