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U.S. Department of Health and Human Services

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

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CYBERONICS INC PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 03/03/2015
Event Type  Death  
Event Description

It was reported that the vns patient passed away. The cause of death was unknown by the physician's assistant. The funeral home director indicated that the patient was buried with the device and that the immediate cause of death was heart failure due to atrial fibrillation >3 years, due to or as a consequence of atrial fibrillation >3 years, due to or as a consequence of sleep apnea >5 years. The death certificate noted other significant conditions contributing to death, but not resulting in the underlying cause was serious anemia. No autopsy was performed. The manner of death was listed as natural, and tobacco did not contribute to the death.

 
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Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key4641033
Report Number1644487-2015-04287
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 03/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number102R
Device LOT Number201883
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/26/2011
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: 03/30/2015 Patient Sequence Number: 1
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