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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 Insufficient Information
Event Date 12/10/2012
Event Type  Death  
Event Description

Reporter indicated that a vns patient had died "peacefully in his sleep" on (b)(6) 2012. An online obituary noted the patient died at home as a result of his epilepsy. It is unknown if seizure activity preceded the death; as such sudep cannot be ruled out as a possible cause of the death. Attempts for additional information are in progress.

 
Event Description

All attempts for the autopsy results from the medical examiner's office have been unsuccessful to date.

 
Event Description

Reporter indicated the vns device was explanted and discarded.

 
Event Description

Reporter indicated the patient's death was not related to the vns, but the cause of the death is unknown and pending an autopsy. The death was not witnessed and no trauma occurred. The patient was noncompliant with taking his medications and did not keep regular office appointments. Attempts for the autopsy results are in progress.

 
Event Description

An autopsy report for the patient was received to the manufacturer on (b)(4) 2013. Final autopsy diagnosis was "epilepsy, unspecified; oro-gastric aspiration, acute splenitis, pneumonia, hypoxic ischemic brain injury, subarachnoid hemorrhage, obesity, hepatic stenosis (mild), mild atherosclerosis of cerebral blood vessels, and superficial abrasions". The manner of death was natural. Blood tests did not detect any anti-epileptic drugs or illicit drugs. No significant injuries were present that caused the death. According to investigative reports, the decedent was found unresponsive after a seizure.

 
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 epilepsy, which was contributed by obesity, pneumonia, foreign body in respiratory tract, and inhalation of gastric contents. 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 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 Key2904662
Report Number1644487-2013-00110
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number202093
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2012
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: 01/09/2013 Patient Sequence Number: 1
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