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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 04/19/2011
Event Type  Malfunction  
Event Description

It was reported that the patient was experiencing an increase in seizures with an unknown relationship to the pre-vns baseline and was experiencing painful stimulation underneath his armpit. Diagnostics taken indicated normal device function; however, the generator was at or near end of service. A rough battery life calculation was performed using dates from 10/09/2002 to 12/27/2006 that confirmed that the generator was likely at end of service. Upon interrogation of the patient's vns, it was found that a faulted diagnostics test had likely occurred, resulting in a change in the patient's settings. The physician indicated that the increase in seizures was likely a result of the decrease in settings. The patient's generator has been replaced due to end of service. Attempts for additional information have been unsuccessful to date.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key2102253
Report Number1644487-2011-01144
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number855099
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/19/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 05/19/2011 Patient Sequence Number: 1
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