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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 11/20/2011
Event Type  Death  
Event Description

On (b)(6) 2012, it was reported that the vns patient has passed away on (b)(6) 2011. Additional information has been requested from the patient's physician but no further information has been received to date. Based on the information received to date, the patient's death is possibly sudep at this time.

 
Event Description

Additional information was received on (b)(6) 2013 when the patient's death certificate was received. The patient passed away on (b)(6) 2011 and the immediate cause of death was noted to be cardiopulmonary arrest, congestive heart failure, atrial fibrillation, and aortic stenosis. The approximate interval between the onset of these events and death was minutes for the cardiopulmonary arrest and years for the congestive heart failure, atrial fibrillation, and aortic stenosis. An autopsy was not performed and the manner of death was stated to be "natural". Good faith attempts for further information from the physician have been unsuccessful.

 
Event Description

Additional information was received on (b)(4) 2013 when the physician reported that there is no relationship between the cardiopulmonary arrest, atrial fibrillation, and congestive heart failure to vns. The events did not occur with stimulation. No causal or contributory programming or medication changes preceded the onset of these events. The physician stated that he believes the patient had a pre-vns medical history of atrial fibrillation and congestive heart failure. The patient had a previous risk factor of "l/v smoking and hypertension" which may have predisposed the patient to myocardial infarctions according to the physician.

 
Manufacturer Narrative

 
Event Description

Additional information is received on (b)(4) 2013 when the physician reported that it is unknown when the patient passed away and the relationship of the patient's death to vns. A copy of the patient's death certificate was requested from the department of vital records in the state the patient passed away in but it has not been received to date.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2892949
Report Number1644487-2013-00006
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/04/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2005
Device MODEL Number102
Device LOT Number7834
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/01/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/10/2003
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: 01/02/2013 Patient Sequence Number: 1
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