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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 06/04/2012
Event Type  Death  
Event Description

Follow-up with the funeral home was done and they did not have the generator or lead for return.

 
Event Description

On (b)(6) 2013 a sudep evaluation was performed by the manufacturer with the information available and it was determined that the patient¿s death is considered to be possibly sudep related.

 
Event Description

It was reported that the patient had not been seen in a long time, and the treating physician was unknown. The company case manager searched online and found an obituary for the patient who passed away on (b)(6) 2012. The reason is unknown. The patient¿s previously treating physician moved a few years prior and no longer practices vns. The patient passed away outside of his care. Review of the company programming history database revealed the patient¿s last programming physician was another physician (on (b)(6) 2010). Attempts for additional information from this physician have been unsuccessful to date.

 
Manufacturer Narrative

Analysis of programming history performed.

 
Event Description

Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was: atherosclerotic heart disease; benign neoplasm of adrenal gland; myocardial degeneration; cardiomegaly; atherosclerosis of aorta. There is no allegation or other information indicating that the death is related to vns.

 
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Brand NamePULSE GEN MODEL 102
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 Key3205872
Report Number1644487-2013-02037
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/12/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2013
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 Number014277
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/19/2005
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: 07/03/2013 Patient Sequence Number: 1
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