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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 02/10/2009
Event Type  Death  
Event Description

On (b)(6) 2011, it was reported by a vns treating nurse that the vns pt had died on (b)(6) 2009 due to pulmonary embolism. The relationship of the death to vns is unk. Since cause of death is known, it is not sudden unexplained death in epilepsy. Add'l info regarding the pt's death has been requested from the nurse, however, no further info has been received to date. If add'l info is received, it will be reported.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
ste 600
houston , TX 77058
2812287200
MDR Report Key2103898
Report Number1644487-2011-01136
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/28/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2005
Device MODEL Number102
Device LOT Number8664
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/28/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2003
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: 05/20/2011 Patient Sequence Number: 1
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