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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 08/04/2014
Event Type  Death  
Event Description

Additional information was received when the physician reported that the patient¿s cause of death was chronic obstructive pulmonary disease (copd). The patient¿s concurrent illnesses at the time of death were noted to be emphysema, copd, asthma, depression, and anxiety. The physician does not believe that the patient¿s death was related to the vns. The patient was noted to be at end stage lung disease and was on oxygen.

 
Manufacturer Narrative

 
Event Description

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

 
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Brand NamePULSE GEN MODEL 103
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 Key4245861
Report Number1644487-2014-03008
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/16/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2013
Device MODEL Number103
Device LOT Number3067
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/19/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/26/2011
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: 11/12/2014 Patient Sequence Number: 1
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