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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PROGRAMMING SOFTWARE

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CYBERONICS INC PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Event Date 01/01/2010
Event Type  Malfunction  
Event Description

It was reported that the handheld's ac adapter cable had a defect causing the handheld to not charge. Troubleshooting was performed, but the problem persisted. Product was returned to the manufacturer, but analysis is pending.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS INC
.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1948993
Report Number1644487-2010-02735
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/04/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2010
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 7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer11/22/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/04/2010
Was Device Evaluated By Manufacturer? No
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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