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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE
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CYBERONICS - HOUSTON PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2009
Event Type  malfunction  
Event Description
A programming history review was performed (b)(6) 2015 and it was found that on (b)(6) 2009 a faulted system diagnostics test changed the patient's settings and no final interrogation was performed.The settings change was not noticed until the next visit on (b)(6) 2012.
 
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Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key5274241
MDR Text Key33410013
Report Number1644487-2015-06670
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2015
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? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received11/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age44 YR
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