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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 06/10/2014
Event Type  Malfunction  
Event Description

It was reported that there were communication issues with the programming system. The wand battery was replaced and the handheld was unplugged from the wall socket. The communication issues resolved when the serial cable was held in a specific orientation. The handheld serial cable has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The products are not expected for return as they are believed to be lost.

 
Manufacturer Narrative

 
Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr omitted that the new serial cable did not resolve the issue.

 
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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 Key3913621
Report Number1644487-2014-01693
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number840143
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/12/2010
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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