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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 Date 03/01/2012
Event Type  Injury  
Event Description

Reporter indicated via clinic notes dated (b)(6) 2012 received to the manufacturer that a patient experienced a new onset seizure type of generalized tonic-clonic seizures in (b)(6) 2012. The seizures initially occurred 1-2 times per month, then increased to 1-2 times per week, and are currently occurring 2 times per week. The patient had vns generator replacement surgery performed on (b)(6) 2013 due to nearing end of service. Attempts for additional information are in progress.

 
Event Description

Reporter indicated the patient did have a new seizure type, but this was not reported by the parents until (b)(6) 2012. Onfi medication was started as an intervention. Nothing precipitated the change in seizure type. The seizure type was described as generalized tonic-clonic lasting 3-4 minutes, followed by sleeping 15-20 minutes. This was first reported on (b)(6) 2012 to occur twice a week, but at the (b)(6) 2012 office visit it was reported to occur "quite infrequent".

 
Manufacturer Narrative

(b)(4).

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2950592
Report Number1644487-2013-00344
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number103
Device LOT Number200969
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/25/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/02/2008
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: 02/08/2013 Patient Sequence Number: 1
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