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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 LYJ   Back to Search Results
Model Number 102
Event Date 03/28/2007
Event Type  Death   Patient Outcome  Other
Event Description

Reporter indicated that a vns pt expired. The pt had been seen by her treating physician for initial vns therapy system dosing the day prior to having expired. There was probable cause to believe it was due to sudep (sudden unexplained death in epilepsy).

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceLYJ
Manufacturer (Section F)
CYBERONICS, INC.
houston TX *
Manufacturer (Section D)
CYBERONICS, INC.
houston TX *
Manufacturer Contact
donnie welty, rn, bsn
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key828303
MDR Report Key841027
Event Key803874
Report Number1644487-2007-00507
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/28/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2007
Device MODEL Number102
Device LOT Number014947
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

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