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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2011
Event Type  Death  
Event Description

Reporter indicated that a vns patient had died, but no other information was provided. Attempts for further information and disposition of the vns device are in progress.

 
Event Description

Information regarding medications and vns settings from the last office visit on (b)(6) 2010 were provided by the reporter. The patient was taking zonegran, gabapentin, calcium, a multivitamin, and carbatrol medications. The last vns settings were 1. 25ma/20hz/130 pulsewidth/30sec on/5 min off/1. 25ma magnet/30 sec on. The death certificate was received to the manufacturer. The cause of death per the autopsy is listed as: "a deep venous thrombosis with pulmonary thromboembolism (hours) due to probable prolonged immobility following seizure (unknown) due to c. Epilepsy (unknown). " follow up with funeral home revealed the patient's vns was explanted before cremation and discarded.

 
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) 2011 and the patient's cause of death was phlebitis and thrombophlebitis of other deep vessels of lower extremities with epilepsy, unspecified, pulmonary embolism without mention of acute or pulmonale, immobility, and other and unspecified convulsions. There is no allegation or other information indicating that the death is related to vns.

 
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Brand NamePULSE GEN MODEL 102R
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 Key2426109
Report Number1644487-2012-00100
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 12/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2005
Device MODEL Number102R
Device LOT Number8773
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 Manufactured07/01/2003
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: 01/12/2012 Patient Sequence Number: 1
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