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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 07/21/2009
Event Type  Injury  
Event Description

It was reported that the vns patient experienced a tonic-clonic seizure following generator replacement surgery and was hospitalized overnight. The patient reportedly never experienced tonic-clonic seizures before the event. Attempts for additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102R
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 Key4442826
Report Number1644487-2015-03683
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 12/29/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number102R
Device LOT Number2187
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/29/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/22/2008
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: 01/22/2015 Patient Sequence Number: 1
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