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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
Event Date 03/07/2013
Event Type  Death  
Event Description

It was reported that a vns patient passed away on (b)(6) 2013. Their death was not related to their vns device but sudep is suspected to be the cause of their death. The pt weighed (b)(6), the etiology of their seizures: iatrogenic hypoglycemia secondary to insulin in the nursery. The patient had quadriparesis, cortical blindness dysphagia and gerd. The patient had seizure reduction with the vns. They were receiving vns therapy treatment at the time of death. They were set to 2. 00 ma,20 sf ,250 pw ,7 seconds on time,30 seconds off time ,2. 25 ma ,60 seconds on time ,250 pw. No products were explanted at the time of death. No autopsy performed, their death was not witnessed. The patient was found pulseless in the am, cold, lying in bed and no signs of a struggle. The patient did have a history of nocturnal seizures. The patient does have a history of mild aspiration with no recent pneumonia at time of death.

 
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Brand NamePULSE GEN MODEL 102R
Type of DevicePULSE 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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3035470
Report Number1644487-2013-00913
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/14/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2009
Device MODEL Number102R
Device LOT Number1970
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/14/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/26/2007
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: 04/04/2013 Patient Sequence Number: 1
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