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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 05/21/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013 it was reported that the handheld was not charging properly. It was stated that the power cord was found to be the problem as the handheld worked fine with an alternative charger. It was stated that the wand and cable adapter are all fine. The nurse said she had dropped the power cord and it hit the floor at the ¿part of the box which connects both the wires¿; since that time it has not worked. When it is connected to the handheld and plugged in there is no charging light at all. It was stated that the device would be returned to the manufacturer for product analysis but it has not been received to date.

 
Event Description

It was reported that the device would be returned for product analysis but it appears to have been lost in the mail as it was reported to have been sent but it was not received by the manufacturer for product analysis.

 
Manufacturer Narrative

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3167335
Report Number1644487-2013-01769
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number857133
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/22/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/07/2010
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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