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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 03/23/2010
Event Type  Injury  
Event Description

It was initially reported by the treating physician that the vns pt's device was turned on (b)(6) 2010, with the pt having a dramatic improvement in her grand mal seizures but since stimulation, the pt has developed what appears to be myoclonic seizures. The physician says the myoclonic seizures act like an aura that proceeds a generalized seizure. The family swipes the magnet when they note the pt is having a myoclonic seizure and the magnet stimulation aborts the generalized seizure. The family reported that one day the pt started having the myoclonic seizure and they couldn't find the magnet and the seizure progressed to a generalized seizure. The physician is planning on doing an eeg to confirm the new seizure type. Good faith attempts to obtain additional info are in progress.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1959483
Report Number1644487-2011-02984
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/07/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number103
Device LOT Number2528
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/07/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2009
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: 01/06/2011 Patient Sequence Number: 1
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