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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/15/2010
Event Type  Death  
Event Description

It was reported that the vns patient passed away. The cause of death and relationship of the death to vns are unknown. No additional relevant information has been received to date.

 
Event Description

The cause of death was listed as pneumonia, septicemia, cardiac arrest, shock. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

The physician indicated that the patient experienced, a reduction in seizures with vns therapy. The patient was receiving therapy at the time of death. The cause of death was listed as paraplegia with respiratory failure. It was noted that no autopsy was performed and the death was not believed to be related to vns therapy. The patient was compliant with medications and suffered respiratory arrest at the time of death.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4281651
Report Number1644487-2014-03164
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/31/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/03/2005
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: 11/26/2014 Patient Sequence Number: 1
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