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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 11/06/2009
Event Type  Injury  
Event Description

It was reported that the recently implanted vns pt is experiencing syncope and pallor, which the mother believes to be a new seizure type. The mother reported to the nurse that two hours after an increase in the device's programmed settings, the pt became pale and absent. The mother explained that this has occurred the last two times the device settings have been increased. Review of the available in house programming history shows that the device settings have been increased incrementally about once a week. Device diagnostics have been regularly performed and the last available history reveals normal device function, which is from a f/u appointment in 2009. Good faith attempts to obtain add'l info have been made, but no add'l info has been received to date.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1577946
Report Number1644487-2010-00059
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/14/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number103
Device LOT Number2323
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/14/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/12/2010 Patient Sequence Number: 1
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