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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/04/2006
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was reported that the patient passed away on (b)(6) 2016. She was found deceased in her home. The physician reported that the patient had cps and gtc seizures along with morbid obesity and depression. The patient was presumably seizure free, according to the physician's report. An autopsy was not performed, but the generator and lead were explanted and discarded. The patient's last visit to her physician was on (b)(6) 2006, and the patient was receiving vns therapy at the time of death to the physician's knowledge. The patient was on topimate and lamotrigine at the time of death. The relationship of the death and vns was unknown since the cause of death was unknown, but the physician did not attribute the death to vns. Additional information was received from the national death index. The cause of death was: major cardiovascular disease, generalized and unspecified atherosclerosis, other obesity, unspecified depressive episode, unspecified epilepsy, unspecified asthma, and unspecified arthrosis. A sudep (sudden unexpected death in epilepsy patients) evaluation was performed based on information from the national death index, and the death was determined to be probable sudep.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5983626
Report Number1644487-2016-02222
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2007
Device MODEL Number102
Device LOT Number013177
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/28/2005
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: 09/28/2016 Patient Sequence Number: 1
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