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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 12/15/2006
Event Type  Death  
Event Description

Reporter indicated a vns patient had died on (b)(6) 2006. No information regarding the death or the relationship of the death to the vns was provided. Attempts for further information are in progress.

 
Event Description

All attempts to the reporter for additional information have been unsuccessful to date. Follow up with the vital records office revealed the cause of death was cardiopulmonary arrest and aortic thrombosis. No autopsy was performed. Follow up with the funeral home revealed the patient was cremated, and the vns was explanted and discarded.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2687342
Report Number1644487-2012-01981
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2005
Device MODEL Number102
Device LOT Number009597
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/10/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/18/2003
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: 08/08/2012 Patient Sequence Number: 1
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