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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

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CYBERONICS PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Event Date 11/16/2011
Event Type  Malfunction  
Event Description

Reporter indicated that a charger power cord for a vns (b)(4) x50 computer was not charging the computer. The power cord ac adapter was returned for analysis. An analysis was performed on the returned ac adapter and the reported allegation was verified. The cause for the reported complaint is associated with a defective 120v ac power cord. Continuity testing of the cord identified that both wire connections were open. A root cause for the open wire connections could not be identified during the analysis. No further anomalies associated with the ac adapter were identified using a known good 120v power cord.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2377525
Report Number1644487-2011-03109
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/16/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMODEL 250
Device LOT Number841226
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2011
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/16/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/25/2010
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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