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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
Event Type  Death  
Event Description

Additional information was received from the physician stating that the vns patient¿s death was unrelated to vns. The patient achieved seizure reduction with vns and was receiving therapy at the time of death. Diagnostic results showed normal device function at the patient last office visit on (b)(6) 2014. Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep.

 
Event Description

It was reported that the vns patient passed away. It was reported that the death certificate lists the cause of death as cardiac arrest, sepsis secondary to peritonitis. A significant condition was listed as seizure disorder. The relationship of the vns to the cause of death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4381874
Report Number1644487-2015-03519
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number103
Device LOT Number201020
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/10/2009
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: 01/05/2015 Patient Sequence Number: 1
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