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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 06/03/2010
Event Type  Death  
Event Description

It was reported by a psychiatrist that a vns pt suffering from depression passed away on (b)(6) 2010. Good faith attempts to obtain more info regarding the relationship of pt's death to vns from the treating physician have been unsuccessful to date. Death certificate was obtained from the corresponding county and the manner of her death was ruled 'natural. ' it also stated that no autopsy was performed on the pt and pt's cause of death was cardiac arrest / sudden death, pulmonary embolism, and asthma.

 
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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 Key2007261
Report Number1644487-2011-00350
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/26/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2007
Device MODEL Number102
Device LOT Number014911
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/26/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2006
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: 02/25/2011 Patient Sequence Number: 1
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