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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101

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CYBERONICS, INC. PULSE GEN MODEL 101 Back to Search Results
Model Number 101
Device Problem Insufficient Information
Event Date 07/27/2010
Event Type  Death  
Event Description

It was reported by the physician's office that the patient has died due to an unknown reason. No other information regarding the patient's death was known by the office or the patient's last known physician. Attempts for a copy of the patient's death certificate have been unsuccessful to date.

 
Event Description

The requested death certificate has been received. The cause of death is listed as "sepsis", "cholecystihs", and "cholerithiasis" as contributing causes. Other significant contributing conditions were listed as: "aspiration pneumonia, seizure disorder, adrenal insufficiency, hypothyroidism. " no autopsy was performed. The manner of death is listed as "natural. " the patient died as an inpatient. The patient's vns is believed to have been buried with the patient.

 
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) 2004 and the patient's cause of death was potential sudep with epilepsy, unspecified, and sequelae of intracranial injury and other accidents. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of definite sudep. There is no allegation or other information indicating that the death is related to vns.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS, INC.
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 Key2265175
Report Number1644487-2011-02245
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2002
Device MODEL Number101
Device LOT Number1353
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2000
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: 09/22/2011 Patient Sequence Number: 1
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