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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2012
Event Type  Death  
Event Description

Reporter indicated a patient implanted with the vns passed away on (b)(6) 2012, due to seizures per the patient's parents. Attempts for additional information are in progress.

 
Event Description

Reporter indicated the cause of death was a seizure and the death was not related to the vns. The vns was not explanted, and there was no autopsy. The patient did have seizure reduction with vns. The vns was programmed on at the time of death. The mother found the patient "half out of bed and cold/blue in am. " the death was not witnessed. The position of the body when found suggests the patient died due to a seizure. The patient had a history of nocturnal seizures but no febrile seizures, and the seizures began at 7 years of age due to an unknown etiology. The patient's seizures were secondary generalized and complex-partial. The patient never had any respective surgery. The patient had no drug/alcohol abuse and no cardiac/respiratory problems.

 
Event Description

Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient's cause of death was status epilepticus.

 
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Brand NamePULSE GEN MODEL 103
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 Key2830680
Report Number1644487-2012-02989
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2012
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL Number103
Device LOT Number3051
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/03/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/11/2011
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: 11/13/2012 Patient Sequence Number: 1
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